215 Iso 13485 Jobs - Page 7

PURPOSE AND RESPONSIBILITIES OF THE POSITION Carry out audits at suppliers in accordance with the reference regulations, Eurofins Sisthema procedures and specific customer requests. Draft audit reports within agreed timelines. DESCRIPTION OF THE ACTIVITIES Macro Areas of Activity Pre-audit Management of pre-audit documents Preparation of the audit agenda Collaboration in travel preparation Audit Conducting the audit Post-audit Drafting of audit reports and audit comments. Drafting amended documents following customer request Evaluation of the CAPA plan CROSS-FUNCTIONAL (INTERNAL AND ETERNAL) RELATIONS Roles and Areas with which links are held Customer Preparation of the audit agenda, drafting of the audit report and audit comments, make any necessary corrections and evaluation of the CAPA plan. Supplier Preparation of the audit agenda, conduct of the audit QA Reporting non-compliances Finance Expenses reporting Audit Sales & Planning Specialist Preparation of the agenda Collaboration for audit planning and travel preparation Audit Sales & Planning Assistant Preparation of the agenda Collaboration for audit planning and travel preparation Audit Customers Manager Collaboration in the technical review of the audit reports. Collaboration following customer requests Audit Operations & Audit Sales Man Collaboration in the auditor qualification process. Reporting issues emerged during the audit Qualifications Educational qualification- Scientific degree (preferably Pharmacy, Chemistry and Pharmaceutical Technology, Chemistry) Technical Audit Report Writing skills are mandatory. Previous experience- Experience of minimum 10 plus years in the field of pharmaceuticals, medical devices and / or cosmetics (QA, Regulatory Affairs, QC, Consulting) Conducting at least 10 supplier audits and/or internal audits Knowledge of- EU GMP part I & II, ISO 9001, ISO 13485, ISO 15378, ISO 22716,CFR21 part 210,211, EU GDP, IPEC guidelines, English language level C, Microsoft Office Specific technical practical skills (know-how) - Conducting Audits of Quality Management Systems Transversal skills- Attention to order and Quality Self-control Autonomy Analytical capacity Customer and result orientation Confidentiality Compliance with planned timelines Additional Information Use of equipment, utilities, software -Microsoft Office, LIMS, SAP, CDS system. Certifications -Quality Management System, Computer System Validation, Six Sigma, ISO

Why join AliveCor ? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that we ve saved lives. Join us in our mission! The Opportunity: AliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and Sales teams to manage product submissions, perform regulatory pre- and post-market analysis, drive product registrations and listings worldwide, and help implement and maintain an ISO 13485 and FDA compliant Quality Management System. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you. Role & Responsibilities Collaborate and execute regulatory strategies for US, Europe and other global registrations Participate in preparation and review of global regulatory submissions Support government/FDA interactions pertaining to medical device registrations and licensing ; Participate in the development of regional regulatory strategy and update strategy based upon regulatory changes; Assist in the review of advertising and promotional materials; Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle; Support or lead regulatory activities required for US FDA, EU MDR, NMPA, PMDA, ANVISA compliance ; Support worldwide resellers and distributors with product registrations and renewals; Provide regulatory assessment for manufacturing and design changes; Provide regulatory review and approval of change order packets; Support or lead product regulatory intelligence and risk assessments; Assist in maintaining compliance with product post market requirements; Support post-market regulatory actions taken for the products; Support internal and external audits; Ensure compliance with internal procedures and external regulations and standards; Maintain regulatory and quality records and other controlled documents; and Promote a culture of quality throughout AliveCor Requirements Bachelors degree in Science, Engineering, Math, or medical field or equivalent educational experience pertaining to technical writing, scientific method, and problem solving 4+ years of experience in medical device Regulatory Affairs Experience in regulatory affairs for software devices with AI/machine learning algorithms (SaMD) Participated in the preparation of pre-submissions, 510(k)s or de novo submissions Experience with and knowledge of EU Medical Device Regulations Ability to manage small projects: organised, independent, and results-oriented Superb analytical and excellent communication skills, strong team ethic, and attention to detail Preferred candidate profile Advanced degree or Regulatory Affairs Certification from RAPS Process-oriented thinking Supported or lead international submissions (preferably in Asia-Pacific and/or LATAM) Demonstrated competence documenting technical information and communicating it to others Perks and benefits We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits Above market family floater medical insurance coverage including both parents or in law parents Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team

Objectives of this role Design and develop hardware products, including circuit boards, components, and systems, while adhering to industry standards and best practices. Generate and maintain hardware design, testing, and quality control documentation. Participate in design reviews, risk assessments, and product validation activities to ensure compliance with regulations. Collaborate with cross-functional teams, including design, development and customer support, to provide feedback and input on product design, performance optimisation, and manufacturability. Your tasks Conduct thorough testing and validation of hardware products to ensure compliance with specifications, requirements and quality standards. Perform root cause analysis and troubleshooting of hardware defects and implement preventive measures for malfunctions to minimise future occurrences. Stay up to date with the latest advancements in hardware testing methodologies and apply them to improve the overall quality of our products. Required skills and qualifications Bachelors degree in Electrical Engineering, Computer Engineering, or a related field. 5+ years of demonstrable experience as a computer hardware engineer. Strong knowledge of hardware design principles, testing tools, equipment, and techniques (mainly PCB designing). Excellent analytical and problem-solving skills with an eye for detail and precision. Ability to work independently and manage multiple tasks simultaneously. Preferred skills and qualifications Proficiency in programming languages, like C/C++ and/or Verilog/VHDL. Familiar with industry regulations in India, like ISO 9001, ISO 13485, BIS and RoHS. Knowledge of hardware regulatory requirements, such as FCC and CE. Strong communication, teamwork, and project management skills.

Your Tasks Responsibilities: Plan and execute product risk management activities together with the project management in an agile development. Work with cross functional teams to identify and evaluate potential safety risks and develop risk mitigation measures for hazardous situations which could occur in the use of the medical devices, health software products and components. Track the implementation of mitigations in close collaboration with product development teams to ensure the effectiveness of the risk control measures. Analyze various industry and regulatory sources of information for potentially applicable risks. Participate in the development and review of the product design inputs and outputs with a focus on risk management. Maintain the contents of the product risk management files. Participate in internal and external audits or assessments. Support continuous growth in excellence of our risk management community and our risk management processes. Qualification And Experience: B.E. / B.Tech / M. Tech Knowledge and Experience: 12-15 years of experience in the medical device industry of which minimum 3 years of risk management experience in SaMD (Software as a Medical Device) is preferred. You have methodological and practical experience in risk management for medical device and health software. You have advanced knowledge about the medical device and its operation/use in customer environment. Good knowledge of relevant product standards such as DICOM, HL7, IHE and clinical workflows is desirable. You know relevant standards and regulations of risk management, e.g., MDR, ISO 14971, IEC 62304, IEC 82304, IEC 62366, ISO 13485. You have experience of working in geographically distributed teams. You have strong communication skills, are assertive and self-motivated with strong analytical and critical thinking skills.

Experience Key Responsibilities: Hands-on experience in aseptic processing of biological/pharma products, including sterile filling, sealing, and packaging. Skilled in operating aseptic equipment and ensuring compliance with GMP, GDP, ISO 13485, and Health Safety standards. Maintains strict hygiene protocols and controlled sterile environments. Proficient in environmental monitoring, aseptic area upkeep, and contamination control. Accurate documentation of batch records, QC logs, and processing reports. Strong foundation in microbiology and pharmaceutical standards, backed by B.Sc./M.Sc./B.Pharm/DMLT qualifications. 1-4 years of industry experience in aseptic manufacturing and sterilization.

Hiring Production Supervisor for a Medical Device Manufacturing company Job Title: Production Supervisor Medical Devices Location: Bengaluru Experience: 5 - 8 Years Department: Manufacturing / Operations Summary of the role: We are seeking a detail-oriented and proactive Production Supervisor to oversee the manufacturing operations of medical devices , with a specific focus on the X-ray tube production line . The role demands strong leadership, technical expertise in high-voltage components, vacuum processing, and precision assembly within cleanroom environments. The ideal candidate will ensure production efficiency, safety, and compliance with ISO 13485 , FDA 21 CFR Part 820 , and Good Manufacturing Practices (GMP) . Key Responsibilities Supervise and coordinate daily activities of production personnel to meet quality and productivity targets. Ensure strict adherence to quality systems ( ISO 13485 ) and regulatory requirements ( FDA 21 CFR Part 820 , GMP). Oversee end-to-end operations of the X-ray tube production line , including oil filling, vacuum sealing, and final encapsulation processes. Monitor production schedules, allocate resources effectively, and ensure timely completion of work orders. Identify, troubleshoot, and resolve production issues, implementing appropriate Corrective and Preventive Actions(CAPA) . Maintain complete and accurate production records, including batch documentation and Device History Records (DHR) . Train, coach, and evaluate production staff on SOPs, safety protocols, and regulatory compliance. Collaborate with cross-functional teams including Quality, Engineering, and Supply Chain to ensure smooth and compliant operations. Support internal and external audits and drive regulatory compliance initiatives. Continuously assess and improve production processes by contributing to Lean manufacturing , 5S , and Kaizen activities. Required Qualifications and Skills Bachelors Degree or Diploma in Engineering(Mechanical, Electrical, Biomedical, or related field). 5+ years of relevant experience in medical device manufacturing , preferably involving high-voltage and vacuum component production. Strong knowledge of ISO 13485 , GMP , FDA 21 CFR Part 820 compliance. Hands-on experience with cleanroom protocols, SOP documentation, and regulated manufacturing environments. Proficiency in handling CAPA, DHR documentation, and batch production reporting. Leadership experience in managing shop-floor teams and cross-functional collaboration. Familiarity with production planning systems and ERP tools is a plus. Key Competencies Leadership & Team Coordination Regulatory Compliance & Documentation Process Troubleshooting & Root Cause Analysis Continuous Improvement Mindset Strong Communication & Interpersonal Skills Attention to Detail and Quality Orientation For further information or any clarification, please reach us on rajbm@mlopssol.com

The Injection Molding Supervisor plays a critical role in overseeing and optimizing the production of high-quality injection-molded components, ensuring compliance with ISO 13485 (Medical Devices) and ISO 15378 (Primary Packaging for Medicinal Products) standards. This position is responsible for managing day-to-day operations, maintaining production efficiency, ensuring adherence to regulatory and quality requirements, and fostering a safe and productive work environment. : Diploma in Mechanical Engineering / Plastic Engineering / CIPET Must-Have Skills:

Role & responsibilities Responsible for documentation related to quality system guidelines. Responsible for maintaining the Company's internal audit program (including quality) and assess improvement initiatives resulting from all Audits internal and external. Monitor activities to ensure compliance with core quality measures. Responsible to close internal and externally identified non-conformities and review the implementation of CAPA plan Represent the management for all external Quality Audits as and when required/directed Conducting the internal audits on timely basis & follow for NCs closure Responsible to visit south warehouses as per management requirement/Customer requirement and report the same to Zonal QA Mentor, QA Head and Zonal Manager Responsible to implement ISO 9001:2015 standard and ISO 13485:2016 standards at south warehouses as per business requirement and customer requirement Responsible to get ISO 9001:2015 standard /ISO 13485:2016 certificate for south warehouses as per business requirement and customer requirement To involve and lead new warehouse projects and new QMS SOPs preparation based on customer requirement and QMS requirement

System Engineer /Sr. Systems Engineer Location: Pune, India Company: InnoIQ Engineering (Subsidiary of B&W Engineering und Datensysteme GmbH, Germany) Industry: Medical Devices / Engineering Services Employment Type: Full-time Role Summary: We are seeking a meticulous and detail-oriented System Engineer to join our growing team. In this role, you will be responsible for translating product needs into clear, structured, and testable requirements and specifications that guide engineering teams through the development of medical devices. You will act as a critical bridge between product management, design, and engineering teams, ensuring that all stakeholder needs are accurately captured and documented. About Us: At InnoIQ Engineering , a proud subsidiary of B&W Engineering und Datensysteme GmbH, Germany , we specialize in the research, design, and development of innovative medical devices . Guided by German engineering principles and a deep understanding of global healthcare needs, we deliver precision, quality, and customer-centric solutions . From early concept to production support, we serve as a strategic engineering partner to leading medical technology companies. TitleSystem Engineer /Sr. Systems EngineerQualification Bachelors or masters degree in Biomedical/ Electronics/Electronics & Telecommunication/Computer/Mechatronics Engineering Expected Experience 5-10 Years of Relevant Experience with minimum 3 years in medical device or other regulated industry Experience in New Product Development (NPD)/New product Introduction and Sustenance Engineering is a must Job Responsibilities Derives requirements from high -level requirements into product level requirements. Develop clear, concise, and testable specifications for hardware and software components of medical devices. Collaborates with multiple teams including client team, marketing/business development teams, technical teams, quality and regulatory teams to decompose needs statements into system product level requirements for medical devices and accessories Maintain traceability matrices and ensure alignment with verification and validation plans Participates in design reviews, including reviews of design inputs and outputs to ensure requirements are feasible and aligned with product goals. Keeps abreast of new developments in all relevant technological domains Envision, Desing, Build innovative solutions for customer Needs, Product & Services Ideation and conceptualization. POC development and prototyping Actively participates in design fraternity by sharing and learning best practices and gets involved in other organization initiatives Required Skills In-depth understanding of both hardware and software for integrated products Experience with tools such as DOORS, Jama, Polarion, or equivalent is a plus. Experience with embedded microprocessors and microcontrollers Experience with Product Design Hands on with ADC/DAC/Chemical Sensors Knowledge of IOT, Bluetooth, Wi-Fi, USB, File System for Embedded Platform Knowledge of global quality and regulatory environment for Medical devices including , FDA, EU MDR, MDD, IEC 60601-1-1(CE marking), ISO 13485, IEC 62304, ISO 14971 Strong understanding of Safety risk management, including FMEA, design mitigations, and risk management standards Strong Customer facing skills Effective verbal/written communication, documentation, presentation and interpersonal skills, as well as the ability to work both independently and as part of team Desirable Skills Firmware Experience with RTOS or Baremetal System level Circuit Modeling with EDA tools(or similar). SPICE Design of experiment (DOE) methodologies Design for excellence viz DFM, DFT, DFR Usability aspects of Medical devices according to HFE/HE75. IEC 62366, IEC 60601-1-6 etc What We Offer: Opportunity to work on cutting-edge medical technologies. Involvement in meaningful projects that directly impact patient care and quality of life A collaborative and innovation-driven work culture. Exposure to international projects and clients. Professional development and training programs. Flexible working hours / Hybrid work / International team / Training programs, etc Competitive compensation and benefits.

We are seeking a detail-oriented and proactive Supplier Quality Engineer (SQE) to ensure that our suppliers consistently deliver high-quality materials and components. The SQE will be responsible for evaluating supplier processes in Electromechanical commodities, conducting audits, managing non-conformances, and driving continuous improvement initiatives to meet company and customer quality standards. Key Responsibilities: Lead supplier approval development initiatives by assessing manufacturing/technology capabilities to improve quality, reduce costs, and enhance delivery performance. Work cross-functionally with engineering, procurement, and production teams to qualify new suppliers and materials. Develop and implement supplier quality assurance plans and procedures. Review and approve supplier PPAPs (Production Part Approval Process), FAI (First Article Inspection) and PSW ( Parts Submission Warrant) reports. Monitor supplier performance using KPIs, on-time delivery, and quality scorecards. Collaborate with suppliers to resolve quality issues, including root cause analysis and corrective/preventive actions (CAPA). Conduct supplier audits and assessments to ensure compliance with quality standards (e. g. , ISO 9001, ISO 13485). Develop strong, ethical relationships with suppliers with good business practices Work Experience Bachelor degree in Engineering (Mechanical/Electrical) from an accredited university 4-8 years of experience in Supplier quality or manufacturing quality engineering in medical/aerospace/Automotive industry Strong knowledge of quality tools and methodologies (e. g. , PPAP, FMEA, SPC, 8D, Six Sigma, MSA). Experience with manufacturing and production processes and engineering principles Excellent analytical, problem-solving, and communication skills. Proficiency in MS Office, ERP and quality management systems (QMS).

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team and play a key role in ensuring the regulatory compliance of our engineering services projects for leading global Healthcare/ MedTech clients. You will work closely with our engineering and quality teams, as well as clients regulatory team, to navigate the regulatory landscape and ensure a smooth and successful product launch. Roles Responsibilities : Collaborate with clients regulatory team to understand their specific regulatory requirements and strategies for its MedTech products. Provide regulatory guidance and support to our engineering and testing teams, ensuring that the system design, development, and testing activities comply with relevant regulations and standards (IEC 62304, FDA guidelines, ISO 13485, etc. ). Assist in the preparation and submission of regulatory documentation, including 510(k) premarket notifications or PMA applications (as applicable), ensuring completeness, accuracy, and adherence to regulatory guidelines. Monitor and track regulatory changes and updates, keeping the team informed of any relevant developments and advising on necessary adjustments to the project plan or system design. Conduct regulatory research and analysis, providing insights and recommendations on regulatory strategies and compliance requirements. Maintain up-to-date knowledge of relevant regulations, standards, and guidance documents related to medical devices. Support internal audits and regulatory inspections, ensuring that all documentation and processes are compliant. Collaborate with cross-functional teams (engineering, quality, marketing) to ensure that regulatory requirements are considered throughout the product lifecycle.

Role & responsibilities: • Be a part of core project team and support the quality engineering across the entire development cycle Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects. Lead the development and implementation of design verification and validation plans with project design lead. Lead the development of Critical to Quality (CTQs), design input and output documents. Lead the fixture qualification and test method validation. Participate and implement tools like Design of Experiments (DOEs), FMEA sessions, Risk Management and ensure compliance to CTQs and safety requirements. Manage electronic document control and version control on all project related documents. Ensure adherence to the quality systems and design assurance SOPs and Boston Scientifics PLCP. Lead usability, reliability, testing, verification and validation testing internal and local vendors. Provide statistical testing and reliability plans. Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution. Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable). Co-Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies). Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed quality. Skill Sets: Must have - Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. Sound understanding of medical device regulatory requirements for Class II and III medical devices. Project planning – resourcing, timelines, quality and budgets. Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Preference for candidates with CQE certification or similar training and experience Proficient in project management tools like MS project. Experience in GD&T with statistical analytical techniques and s/w tools like Keywords & Tools: Quality Management Systems ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. Sound understanding of medical device regulatory requirements for Class II and III medical devices. development of Critical to Quality (CTQs) Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Well versed MATLAB, MINITAB. GD&T CQE certification, CAPA

Job Summary: We are seeking a detail-oriented and proactive Supplier Quality Engineer (SQE) to ensure that our suppliers consistently deliver high-quality materials and components. The SQE will be responsible for evaluating supplier processes in Electromechanical commodities, conducting audits, managing non-conformances, and driving continuous improvement initiatives to meet company and customer quality standards. Key Responsibilities: Lead supplier approval & development initiatives by assessing manufacturing/technology capabilities to improve quality, reduce costs, and enhance delivery performance. Work cross-functionally with engineering, procurement, and production teams to qualify new suppliers and materials. Develop and implement supplier quality assurance plans and procedures. Review and approve supplier PPAPs (Production Part Approval Process) and FAI (First Article Inspection) reports. Monitor supplier performance using KPIs, on-time delivery, and quality scorecards. Collaborate with suppliers to resolve quality issues, including root cause analysis and corrective/preventive actions (CAPA). Conduct supplier audits and assessments to ensure compliance with quality standards (e.g., ISO 9001, ISO 13485). Develop strong, ethical relationships with suppliers with good business practices Qualifications: Diploma / Bachelor s degree in Engineering (Mechanical) from an accredited university 3+ years of experience in Supplier quality or manufacturing quality engineering in automotive or aerospace. Strong knowledge of quality tools and methodologies (e.g., PPAP, FMEA, SPC, 8D, Six Sigma). Experience with manufacturing and production processes and engineering principles Excellent analytical, problem-solving, and communication skills. Proficiency in MS Office, ERP and quality management systems (QMS).

Role & responsibilities : Act as the lead internal auditor for medical device programs, ensuring compliance with ISO 13485 and U.S./EU regulations. Investigate non-conformances and implement effective corrective actions for medical device-related issues. Review onboarding checklists to ensure FDA and EU MDR requirements are met for all devices. Oversee compliance in shipping, labeling, and depot processes for investigational and commercial devices. Serve as the main contact during ISO 13485 audits and coordinate with logistics and external auditors. Monitor regulatory changes (FDA, EMA, MDR) and update quality systems accordingly. Administer the EDMS platform, managing system operations, user support, and maintenance. Manage controlled document lifecycles, ensuring version control, timely reviews, and audit readiness. Promote compliance awareness across delivery teams and collaborate with cross-functional stakeholders. Demonstrate strong problem-solving, communication, and virtual collaboration skills, with the ability to explain risk to non-technical teams. Required Experience and Educational Qualification: 10+ years of experience in medical device compliance or quality roles within the pharma, biotech, or medical device industry. Proven expertise in ISO 13485 implementation, audit participation, and regulatory compliance. Solid understanding of FDA 21 CFR Part 820, EU MDR (Regulation (EU) 2017/745), and international medical device standards. Experience with depot and shipping logistics for clinical or commercial medical devices. Strong analytical, documentation, and communication skills. Familiarity with EU authorized representative and UDI requirements. Knowledge of document control processes in support of GxP operations (GMP, GVP, GCP). Familiarity with change control, IT compliance, and CAPA systems.

The Global Quality Data Management Analyst position is responsible for managing all data management tasks for the Quality and Regulatory Affairs organization in order to monitor the overall performance of the QMS related to product performance across the lifecycle of the device and to proactively determine actions plans as applicable. The primary responsibility is to perform trend analysis activities, data mining and reporting, as well as working on delivering various quality reports and assisting other groups such as Design Assurance, Quality Assurance, Engineering, Operations, New Product Development, Marketing and Business Units in management of end user customer experience and market activities, as needed. Responsibilities: Assist with providing inputs to data management & analysis SOPs to ensure consistency and quality within data management activities related to, but not limited to: Quality System, PMS, training, audits, management review, document control and risk management Works closely with the GQRA and cross functional plant Quality Management teams to determine the most adequate way to track and trend quality data Analytical reporting- responsible to run Quality data and reports in accordance with the procedures utilizing BW4, Power BI, and/or excel Using statistical techniques, this position is responsible of generating specific queries to support growing / changing business and market needs, operations and compliance activities Prepares weekly and monthly trend reports on Quality data and shares with Global cross functional Quality and Regulatory Teams Performs lot analysis on quality data Performs regular and on-demand market saturation rate prediction models / estimates together with management Perform on-demand post launch product performance analysis for spring and Change Control process Review vigilance and other databases for relevant complaint information in support to the risk management activities Provide regular updates to the business regarding the Quality data Prepares for and assists with leading the product performance trend meetings (weekly FACTS meeting, monthly Monthly Management Review (MMR)) Prepares and Leads Quarterly Global Country Calls and presents on current quality trends and updates to product performance data. Assesses and provides inputs to different Regulatory Data Analytical Databases Support internal and external audits Other duties as needed or required Essential Functions of the Role**: Very little physical effort required to perform normal job duties (unless otherwise indicated) Must have manual dexterity (use of mouse, keyboard), to type and enter data in the computer as well for preparing presentations Travel 10% Work Experience Requirements Number of Overall Years Necessary: 2-5 Experience in the medical device industry is highly preferred in the areas of data analysis, complaints, CAPA, Quality Education Requirements Bachelors degree in science, engineering, statistics or related discipline Experience with ISO 13485, 21 CFR 820, MDD / MDR, ISO 14971 Specialized Skills/Technical Knowledge: In depth knowledge of statistical tools ( SPC, trend analysis, six sigma) Excellent oral and written communication skills Excellent interpersonal skills Ability to work on multiple assignments and balance priorities to meet timelines. SAP and Excel Microsoft Power BI Platform (M, DAX, Dataflows/cloud service, Data Modeling, and Reporting) Problem solving skills Mode - Hybrid

Why join AliveCor? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting. The Opportunity: AliveCor seeks a Quality System Specialist join this exciting start-up that is changing the face of mobile health. In this role, you will be responsible for the hands-on, day-to-day support of AliveCor’s Quality Management System (QMS) to ensure compliance to company procedures, FDA QSR, ISO 13485, EUMDR and other regulatory standards. Main duties include the processing and maintenance of all QMS-related documents and records, related to product design history files, CAPAs/NCs, training, external standards, suppliers, audits, and calibration. Additional responsibilities include supporting internal and external audits and quality improvement initiatives. This role requires the candidate to be based out of our office in Bangalore, India. Responsibilities: Support the Quality Systems Manager in the management of AliveCor’s QMS Maintain AliveCor’s electronic document control database to ensure the efficiency of AliveCor document control process and compliance to AliveCor and regulatory standards Manage creation, revision, and obsolescence of SOPs, Work Instructions (WRKs), and forms in accordance with document control procedures and assist AliveCor team members with processing of urgent documents, reminders, and status updates, as needed Assist in compiling and organizing design inputs, risk management files, verification/validation reports, and other technical documentation. Support new product development teams in maintaining robust design controls by verifying that Design History Files (DHFs) accurately reference the current document numbers, revisions and associated Quality Records. Manage training records and assignments for quality-controlled procedures, including coordinating document revisions, running overdue training reports, sending overdue reminders, administering quizzes, facilitating password resets, and maintaining records per retention policies. Assist CAPA and NC owners with ensuring completeness of records. Prepare monthly meeting metrics, maintain logs, and send reminders for required activities (i.e. due dates and effectiveness checks) Manage and maintain the Approved Supplier List (ASL), ensure documentation is up-to-date for all suppliers, and coordinate activities related to supplier qualification, periodic re-evaluation, and audits in accordance with the Supplier Control procedures. Assist in the preparation of documents/metrics for Management Review meetings and maintain meeting records Support internal, supplier, and regulatory audits by ensuring documentation readiness, process adherence, compiling required deliverables, and tracking post-audit findings through to timely corrective action and closure. Maintain comprehensive calibration logs, coordinate timely calibration activities with internal teams or external metrology vendors, ensure accurate documentation of all measuring and monitoring equipment, and proactively verify compliance with established calibration schedules and quality standards. Support the integration of new requirements into the Quality Management System and applicable procedures to ensure ongoing compliance. Coordinate, manage, and lead programs related to quality improvement or business objectives as assigned by Quality System Manager and assist other functional areas, as needed Requirements: Bachelor’s degree in Science or Engineering 5+ years of document control, QMS management, supplier management, and/or training administration function in the medical device or other regulated industry Working knowledge of FDA QSR (21 CFR 820), ISO 13485, EUMDR and applicable standards (ISO 14971, IEC 62366, etc.). Prior experience with electronic document management systems and/or learning management systems (LMS). Experience with Master Control is a plus Knowledgeable of Good Documentation Practices to perform and execute job responsibilities with a high level of accuracy Demonstrated ability to communicate effectively with internal and external customers and develop expertise to provide improved assistance Have good communication skills, both written and verbal. Strong editorial and technical writing skills a plus Excellent organisational skills along with strong attention to detail Ability to work both independently and collaboratively with small, cross-functional teams Highly proficient with Microsoft Office Suite and Adobe Acrobat Perks and benefits: We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team

The Role of the Associate Engineer (AE1/AE2) in Quality department is to prepare Work Instructions, line audit, FAR, FMEA, Control plan, Customer report preparation. To maintain and improve the Quality control stage and support the Organization to meet the required KPI s. Academic Qualification / Job Qualification: Diploma in EEE or ECE or E & I or Mech with more than 5 ~6years experience (or) BE in EEE or ECR or E&I or Mech with 4 - 5 years experience Skills / competence required to perform the Job : 1. Team player 2. Good knowledge in MS Office. 3. Good communication & interpersonal skills 4. Experience in EMS or OEM industry preferably Electronics Manufacturing industry 5. System Knowledge of ISO 13485/AS9100 / ISO 9001/TS16949 6. Knowledge in Seven QC tools, CAPA 7. Knowledge on IPC 610 Standards. Responsibilities: 1. To prepare and update work instructions for the products. 2. FMEA & Control Plan document Preparation for the Products being handled. 3. Daily monitor the Yield trends & Performances. 4. Drive CFT for the internal and Customer failures 5. Review customer documents, drawings and specifications to incorporate in internal procedure 6. To prepare the Customer Weekly/Monthly Reports. 7. Preparation of CoC / CoA and release of shipment. 8. Preparation of FAR 9. Conduct process audit across the manufacturing process and drive CFT. 10. DHR (Device History Record) preparation, coordination and release 11. Monitor and support the NCMR & RMA process 12. Active participation in EHS related activities. 13. Ensure ESD compliance .

What you will do In this vital role You will play a key role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content. Role Description: In this vital role as Senior Manager Information Systems, you will lead a dynamic team of technical product owners, business analysts, developers, test/validation engineers, project managers and scrum masters responsible for the ongoing design, development, management, and optimization of Amgens digital products enabling the regulatory submission content automation initiative. You will also be the reporting manager for this team and will be responsible for the coaching and development of these resources. The ideal candidate will have a consistent track record of leadership in technology-driven environments with a passion for fostering innovation and excellence in the biotechnology industry. The role requires deep expertise in handling the end-to-end development and delivery of customer-facing digital product capabilities and platforms including generative AI, structured content management. They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. Extensive collaboration with global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle, technical product ownership, business analysis, be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Maintain strategic relationships and strong communication with the leadership team to ensure all collaborators feel informed and engaged Oversee the software development lifecycle, ensuring standard methodologies in development, testing, and deployment across the product teams Lead and handle large, teams with varied strengths within a matrixed organization, collaborating with geographically dispersed teams, including those in the US and international locations Develop and implement strategic plans for technology and workforce growth, including recruiting top talent and building a robust team in India Developing talent, motivating the team, delegating effectively, championing diversity within the team, and acting as a role model of servant leadership Ensuring global ways of working are embedded in the local organization Develop a culture of collaboration, innovation, and continuous improvement, driving talent development, motivation, and effective delegation Fostering standard methodology sharing and alignment with business goals Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet Participate in team member and leadership meetings, working with other parts of the organization and functional groups to ensure successful delivery and alignment with strategy, compliance, and regulatory requirements Remain accountable for ensuring overall organizational compliance with quality and GxP in technology services Monitor emerging technologies and trends to find opportunities for platform growth and expansion Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with 10 - 12 years of experience in Engineering, IT or related field OR Bachelors degree with 12 - 14 years of experience in Engineering, IT or related field Background as a Technical Product Owner (TPO), people manager, and business analyst, ensuring the ability to oversee and guide a team to translate business needs into definition and delivery of technical solutions, guiding development teams, prioritizing features, and ultimate delivery and management of the digital products. Proven experience working with large-scale data environments comprising data pipelines, and enterprise cloud solutions. In-depth knowledge of data engineering concepts, ETL processes, and data architecture principles. Strong understanding of cloud computing principles, particularly within the AWS ecosystem Working knowledge of 21 CFR, ISO 13485 and experience working in regulatory environments Proven leadership skills with the ability to lead large matrixed teams. In addition, demonstrated experience in leading and developing a hard-working team of technology professionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements. Experience in implementing a strategic roadmap and driving transformation initiatives using Scaled Agile methodology. Strong skills in collaborating and communicating with cross-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Degree in Computer Science, Information Systems, Engineering, or Life Sciences. Preferred Qualifications: At least 5-8 years of domain knowledge in health and/or life sciences combined with Information Technology Proficiency in Python/PySpark development, Fast API, PostgreSQL, Databricks, DevOps Tools, CI/CD, GitLab, and Data Ingestion. Understanding, and preferably applied experience and knowledge, in data management and CTD document drafting Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation. Experience driving a collaborative culture that values technical depth, accountability, and customer service. Strong problem-solving and analytical skills. Demonstrated ability to work effectively in a fast-paced, dynamic environment. Understanding of ITIL processes and implementation. Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills.

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quality Audit and maintain the company anytime audit ready. Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs. To monitor & handle market complaints. Conduct Management review at site. Conduct Calibration of instrument & Maintain Calibration Matrix . Ensure that a respective Change Control procedure is in place and adhered to . Process validation protocol preparation & implementation. Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance. Must be capable to handle all types of Audit. To Lead and face the regulatory audits and close all queries and NC in stipulated time. To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File. Preferred candidate profile: Graduate in Science or Engineering . Post Graduation preferred. Thorough Experience in quality and regulatory areas. Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001. Regulatory functions throughout the organization including monitoring , improvement , audits, and team building. Thoroughly conversant with technical documentation requirement and preparation. Excellent MS office skills. Should have faced multiple audits from multiple agencies Should have thorough knowledge of the applicable standards Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.

A Day in the Life In this role, this role will partner with Quality System team members to generate, analyze, communicate, and follow up with stakeholders to actions related to standard reports for the following QMS processes: -Periodic Review of QMS procedures -Training coming due and/or overdue notifications -Quality Data Analysis (QDA) In addition, this role will assist in the retrieval, review, and archival of Allograft Tissue Tracing Records. Responsibilities may include the following and other duties may be assigned: Communicates and collaborates with internal stakeholders such as Quality, R&D, Regulatory, Operations, Service and Repair, Supplier Quality, Procurement, Operations Quality, and Program Management Office across the following CST QMS entities: o Boxborough o Caesarea o Fort Worth CSF o Fort Worth MPSS o Lafayette o Memphis Pyramid o Memphis SGT Generates and analyzes standard reports (e.g., Periodic Review, Training and Quality Data Analysis) for compliance with KPIs, identification of patterns of underperformance to KPIs Communicates coming due and/or overdue notifications for Training and Periodic Reviews to affected personnel, their management, and Quality leadership Coordinates with internal stakeholders to implement corrections to Agile MAP with regards to Document and Process Owners Coordinates with internal stakeholders to implement corrections to Cornerstone with regards to removal of unnecessary trainings Coordinates with Quality System Program Manager on the generation of standard reports for QDA, preparation of presentations, coordination with data providers and reviewers, and processing of records within Agile MAP Required Knowledge and Experience Bachelor degree; Engineering or Science degrees preferred 3+ years quality assurance experience in medical or pharmaceutical industry Familiarity with medical device Quality Management System requirements (e.g., US 21 CFR Part 820, ISO 13485:2016, Regulation (EU) 2017/745) Experience running data queries and reports in software applications Strong verbal and written communication skills and ability to work in a team oriented environment Agile PLM knowledge/experience Ability to work independently once trained Ability to be proactive and lead initiatives Ability to multitask. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

Responsibilities: * Prepare documentation according to ISO 13485 standards. * Ensure compliance with EU MDR, US FDA & CDSCO guidelines. * Maintain regulatory documentation * Internal Audits

Experienced Candidates in QA as per ISO 13485 review batch records, handle deviations, CAPA, and audits; support validations; write and maintain SOPs; coordinate with cross-functional teams, documentation, and Compliance with regulatory standards. Required Candidate profile Graduate / Post Graduate in biotechnology / bio medical / Microbiology / Chemistry with strong hands on experience in QA operations in any Pharma or medical devices company.

Objectives of this role Design and develop hardware products, including circuit boards, components, and systems, while adhering to industry standards and best practices. Generate and maintain hardware design, testing, and quality control documentation. Participate in design reviews, risk assessments, and product validation activities to ensure compliance with regulations. Collaborate with cross-functional teams, including design, development and customer support, to provide feedback and input on product design, performance optimisation, and manufacturability. Your tasks Conduct thorough testing and validation of hardware products to ensure compliance with specifications, requirements and quality standards. Perform root cause analysis and troubleshooting of hardware defects and implement preventive measures for malfunctions to minimise future occurrences. Stay up to date with the latest advancements in hardware testing methodologies and apply them to improve the overall quality of our products. Required skills and qualifications Bachelors degree in Electrical Engineering, Computer Engineering, or a related field. 5+ years of demonstrable experience as a computer hardware engineer. Strong knowledge of hardware design principles, testing tools, equipment, and techniques (mainly PCB designing). Excellent analytical and problem-solving skills with an eye for detail and precision. Ability to work independently and manage multiple tasks simultaneously. Preferred skills and qualifications Proficiency in programming languages, like C/C++ and/or Verilog/VHDL. Familiar with industry regulations in India, like ISO 9001, ISO 13485, BIS and RoHS. Knowledge of hardware regulatory requirements, such as FCC and CE. Strong communication, teamwork, and project management skills.

Work Flexibility: Hybrid What you will do: Coordinate with partners/end users to deliver value to business through opportunity identification, execution, and solution delivery. Ensure quality of process and product as defined in the appropriate operation and material specifications. Will select components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols. May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation. Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings. Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product launches. Complete capability studies for in process inspection and generate subsequent Inspection documentation. Conduct MSA studies for new products and new processes. Provide training for manufacturing team members. Who we want: Minimum Requirements: Bachelor s degree (B.E.) in Mechanical or related engineering discipline required. 3+ years of work experience required ; Analytical problem solvers; Dedicated achievers and Collaborative partners Preferred Qualifications: Good knowledge of manufacturing processes, materials, product, and process design Project Management experience Ability to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing. Experience in an FDA regulated or ISO 13485 regulated industry- highly preferred. Good understanding of Design for Manufacturing (DFM) related statistical tools and validation/verification technique Travel Percentage: None

Why join AliveCor? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting. The Opportunity: AliveCor seeks a Quality System Specialist join this exciting start-up that is changing the face of mobile health. In this role, you will be responsible for the hands-on, day-to-day support of AliveCor s Quality Management System (QMS) to ensure compliance to company procedures, FDA QSR, ISO 13485, EUMDR and other regulatory standards. Main duties include the processing and maintenance of all QMS-related documents and records, related to product design history files, CAPAs/NCs, training, external standards, suppliers, audits, and calibration. Additional responsibilities include supporting internal and external audits and quality improvement initiatives. This role requires the candidate to be based out of our office in Bangalore, India. Responsibilities: Support the Quality Systems Manager in the management of AliveCor s QMS Maintain AliveCor s electronic document control database to ensure the efficiency of AliveCor document control process and compliance to AliveCor and regulatory standards Manage creation, revision, and obsolescence of SOPs, Work Instructions (WRKs), and forms in accordance with document control procedures and assist AliveCor team members with processing of urgent documents, reminders, and status updates, as needed Assist in compiling and organizing design inputs, risk management files, verification/validation reports, and other technical documentation. Support new product development teams in maintaining robust design controls by verifying that Design History Files (DHFs) accurately reference the current document numbers, revisions and associated Quality Records. Manage training records and assignments for quality-controlled procedures, including coordinating document revisions, running overdue training reports, sending overdue reminders, administering quizzes, facilitating password resets, and maintaining records per retention policies . Assist CAPA and NC owners with ensuring completeness of records. Prepare monthly meeting metrics, maintain logs, and send reminders for required activities (i.e. due dates and effectiveness checks) Manage and maintain the Approved Supplier List (ASL), ensure documentation is up-to-date for all suppliers, and coordinate activities related to supplier qualification, periodic re-evaluation, and audits in accordance with the Supplier Control procedures. Assist in the preparation of documents/metrics for Management Review meetings and maintain meeting records Support internal, supplier, and regulatory audits by ensuring documentation readiness, process adherence, compiling required deliverables, and tracking post-audit findings through to timely corrective action and closure. Maintain comprehensive calibration logs, coordinate timely calibration activities with internal teams or external metrology vendors, ensure accurate documentation of all measuring and monitoring equipment, and proactively verify compliance with established calibration schedules and quality standards. Support the integration of new requirements into the Quality Management System and applicable procedures to ensure ongoing compliance. Coordinate, manage, and lead programs related to quality improvement or business objectives as assigned by Quality System Manager and assist other functional areas, as needed Requirements: Bachelor s degree in Science or Engineering 5+ years of document control, QMS management, supplier management, and/or training administration function in the medical device or other regulated industry Working knowledge of FDA QSR (21 CFR 820), ISO 13485, EUMDR and applicable standards (ISO 14971, IEC 62366, etc.). Prior experience with electronic document management systems and/or learning management systems (LMS). Experience with Master Control is a plus Knowledgeable of Good Documentation Practices to perform and execute job responsibilities with a high level of accuracy Demonstrated ability to communicate effectively with internal and external customers and develop expertise to provide improved assistance Have good communication skills, both written and verbal. Strong editorial and technical writing skills a plus Excellent organisational skills along with strong attention to detail Ability to work both independently and collaboratively with small, cross-functional teams Highly proficient with Microsoft Office Suite and Adobe Acrobat Perks and benefits: We strive to make your life outside work as smooth as possible while youre at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team