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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

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and company s procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development and lifecycle management of final product align with dynamic global regulations and standards. The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercialization. In addition, this role will also support various aspects of the product lifecycle including complaint investigations, expansion and transfer of products to new manufacturing sites, inspection readiness activities, and platform support and improvements. Responsibilities: Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for combination and non-combination products associated with final product activities. Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs. Train and educate key functional partners and management on combination product requirements, standards and regulations Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of final product programs Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on-body injector systems, and accessories. Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging. Provide independent design review for other programs Provides quality oversight of the development, qualification, validation, transfer and maintenance of physical test methods including sample selection NOTE: This role may require working in shifts or extended hours within the same shift What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of Quality experience OR Bachelor s degree and 6 to 8 years of Quality experience OR Diploma and 10 to 12 years of Quality experience Preferred Qualifications: 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus) Bachelor s Degree in a Science Field Ability to oversee multiple medium complexity projects simultaneously Working knowledge of quality engineering and/or mechanical engineering Familiar with final products including applicable guidance, regulations and standards (e. g. , MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211) Prior experience working as part of a combination product launch team Able to successfully manage workload to meet timelines Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving decision making by using Decision, Advice and Inform (DAI) principles Understanding of industry requirements/expectations of a Quality Management System (QMS) Understanding of the applicable manufacturing/testing processes (i. e. Active Pharmaceutical Ingredient, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution of technical standards, internal requirements, and regulations Comfortable with both drug and device terminology Ability to travel +/- 15-20% of time to domestic and international Amgen sites What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com .

A Day in the Life SUMMARY OF POSITION The Software Engineer II V V will be responsible for analyzing the requirements, developing the test protocols for product verification and validation of complex electro-mechanical medical devices as per the regulatory standards ESSENTIAL DUTIES AND RESPONSIBILITIES Technology Support. Participate in Sprint planning. Familiarity and project scope and timelines. Understanding overall feature requirements, test automation framework and developing automation scripts Work closely with system and software Accountable for developing document artifacts as per QMS process. Make sure the testing protocol covers the requirements Traceability analysis to make sure no requirements left uncovered. Automation - work with system and software to define the automation protocols Proactively identify technical limitations and roadblocks if any bring to the table for discussion and suggest solutions. Understand the technological and VV challenge. Understand the details as required. PRINCIPAL WORKING RELATIONSHIPS Reports to the Engineering Manager Interface with VV Lead Frequent interaction with team members from other disciplines, particularly hardware engineers, to develop project requirements and other project artifacts such as project schedules. Possible interaction with clinicians, third-party vendors, manufacturers, subcontractors and other users. EXPERIENCE 5-7 years of software testing experience (preferably medical device) including writing tests protocols and execution At least one year of Test automation experience is added advantage KNOWLEDGE, SKILL, AND ABILITY Experience with both manual testing, Analyzing the requirements and deriving test cases as per quality procedure Identify the ay gaps in requirements or resolve ambiguity in requirements working with the SMEs. Experience working on Ubuntu/Linux and/or Windows Applications. OS, Application installation, configuration, preparing the test data. Experience with Requirements Management tools, configuration management tools. Experience with modern software testing tools and methods, including validation of object-oriented systems. Experience in scripting/ programming languages like Python, JavaScript. Knowledge of object-oriented programming concepts, analytical and logical thinking skills. Good written and oral communication skills to effectively update status, risks, dependencies. Organizational skills essential Self-learning capabilities Good communication and interpersonal skills Collaborate with developers, engineering teams Good team player Good to Have: Experience in regulatory industry in an added advantage Familiarity with FDA regulations and recommended practices, especially regarding software. Familiarity with ISO 13485, ISO 14971, IEC 62304 and other relevant industry standards EDUCATION Required: - B.E or B.Tech in Computer Sciences, Electronics or Electrical Engineer. Preferred: - M.E or M.Tech in Computer Sciences, Electronics or Electrical Engineer. Benefits Compensation 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 RD 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

A Day in the Life SUMMARY OF POSITION The Software Engineer II V V will be responsible for analyzing the requirements, developing the test protocols for product verification and validation of complex electro-mechanical medical devices as per the regulatory standards ESSENTIAL DUTIES AND RESPONSIBILITIES Technology Support. Participate in Sprint planning. Familiarity and project scope and timelines. Understanding overall feature requirements, test automation framework and developing automation scripts Work closely with system and software Accountable for developing document artifacts as per QMS process. Make sure the testing protocol covers the requirements Traceability analysis to make sure no requirements left uncovered. Automation - work with system and software to define the automation protocols Proactively identify technical limitations and roadblocks if any bring to the table for discussion and suggest solutions. Understand the technological and VV challenge. Understand the details as required. PRINCIPAL WORKING RELATIONSHIPS Reports to the Engineering Manager Interface with VV Lead Frequent interaction with team members from other disciplines, particularly hardware engineers, to develop project requirements and other project artifacts such as project schedules. Possible interaction with clinicians, third-party vendors, manufacturers, subcontractors and other users. EXPERIENCE 5-7 years of software testing experience (preferably medical device) including writing tests protocols and execution At least one year of Test automation experience is added advantage KNOWLEDGE, SKILL, AND ABILITY Experience with both manual testing, Analyzing the requirements and deriving test cases as per quality procedure Identify the ay gaps in requirements or resolve ambiguity in requirements working with the SMEs. Experience working on Ubuntu/Linux and/or Windows Applications. OS, Application installation, configuration, preparing the test data. Experience with Requirements Management tools, configuration management tools. Experience with modern software testing tools and methods, including validation of object-oriented systems. Experience in scripting/ programming languages like Python, JavaScript. Knowledge of object-oriented programming concepts, analytical and logical thinking skills. Good written and oral communication skills to effectively update status, risks, dependencies. Organizational skills essential Self-learning capabilities Good communication and interpersonal skills Collaborate with developers, engineering teams Good team player Good to Have: Experience in regulatory industry in an added advantage Familiarity with FDA regulations and recommended practices, especially regarding software. Familiarity with ISO 13485, ISO 14971, IEC 62304 and other relevant industry standards EDUCATION Required: - B.E or B.Tech in Computer Sciences, Electronics or Electrical Engineer. Preferred: - M.E or M.Tech in Computer Sciences, Electronics or Electrical Engineer. Benefits Compensation 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 RD 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

Role & responsibilities: Process Development &Optimization Define, document, and improve engineering workflows, protocols, and D&D procedures. Collaborate with cross-functional teams (Design, QA/RA, Manufacturing, Supply Chain) to standardize and streamline development processes. Support Design Control processes including Design Inputs/Outputs, Verification, and Validation activities. Technical Documentation Management Create, maintain, and control engineering documentation such as: Design History Files (DHF) Device Master Records (DMR) Engineering Change Orders (ECO) Risk Management Files (ISO 14971) Ensure traceability and version control using QMS tools. Assist in the preparation and formatting of documents for regulatory submissions (FDA, EU MDR). Compliance & Quality Support Ensure documentation and processes meet applicable standards: ISO 13485, 21 CFR Part 820, IEC 60601, and other regulatory requirements. Support internal and external audits by providing required documentation and process maps. Knowledge Transfer & Team Support Maintain structured repositories of technical documentation and templates. Train engineers and D&D staff on documentation best practices, process adherence, and use of documentation tools. Tools & Systems Use and help maintain Product Lifecycle Management and Quality Management Systems (QMS). Work with tools such as SolidWorks PDM, Windchill, Arena, or equivalent for document and change control. Preferred candidate profile

Role & responsibilities Manufacturing Drawing Preparation Create 2D manufacturing drawings and 3D models of mechanical components and assemblies. Generate: Part drawings with all required views, sections, and dimensions Assembly drawings with ballooning, BOM integration, and exploded views Fabrication drawings for sheet metal, welded structures, machined components, and plastic parts Apply appropriate Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 or ISO standards. Define tolerances , surface finish , material specifications , welding symbols , and heat treatment notes . Incorporate machining allowances , fits , and limits for manufacturing feasibility. CAD & Drafting Tools Use CAD software such as AutoCAD & SolidWorks for design and detailing. Work with 3D assemblies and extract drawing views, sections, and details as per drawing standards. Manage CAD files and revisions. Drawing Review & Updates Revise drawings based on feedback from engineers, production teams, and design changes. Ensure drawing clarity, completeness, and compliance with internal and industry standards. Support Design for Manufacturing (DFM) and Design for Assembly (DFA) reviews. Documentation & Control Maintain structured drawing repositories with proper naming conventions, revision history, and change tracking. Support document control and release processes through QMS or PLM systems. Preferred candidate profile

We are seeking a PMS and Complaint Analyst with 4 to 6 years of expertise in ISO13485, ISO14971, ISO 62304 (Plus) MDR and EUMDR requirements will be a plus. Requirements: Experience in Complaint handling and PMS for Medical products. In-depth knowledge of Software product development lifecycle. Hands on with complaint management tools such as track wise Is plus. Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers and Manufacturing personnel to facilitate the complaint handling process globally Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint. Initiate complaint in process and applicable tool. Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint. Communicate with customers, call center reps and FSEs to gather more data on complaints as needed. Assess if the Risk assessment is covering the hazard in the complaint. Complete all needed records in a timely and accurate manner Confirm complaint condition and determine corrective action including CAPA as needed. Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed. Evaluate, investigate and resolve complaints. Completes the initial assessment of reportability and escalates to manager to determine action when necessary. Analyzes complaint data, gathers additional data as needed and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects and safety evaluations and resolves complaints. #LI-BL2 #LI-Hybrid

What you will do: Complaint handling and Product investigations of medical devices Perform Visual, functional, dimensional, functional inspection & RCA of field returned products. Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities. Risk management -Risk assessment Review of Process flow, DHR, Inspection plans, Measurement techniques, GRR s etc. Review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis. Other tasks as assigned by manager. What you need: Required skills: B. Tech / M.Tech Mechanical, Biotechnology with 2-5 years of work experience Hands on experience of Complaint handling and product investigations process.Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability. Hands on experience of Risk Management process as per ISO 14971 Sound knowledge on complaint handling process of medical devices will be an added advantage Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).Good understanding of FDA 21CFR Part 822 / 820 (Good to have) Preferred skilla: Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies. Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams. Travel Percentage: 20%

What you will do Complaint handling and Product investigations of medical devices Perform Visual, functional, dimensional, functional inspection & RCA of field returned products. Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities. Risk management -Risk assessment Review of Process flow, DHR, Inspection plans, Measurement techniques, GRR s etc. Review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis. Other tasks as assigned by manager. What you need: Required skills: B. Tech / M.Tech Mechanical, Biotechnology with 2-5 years of work experience. Hands on experience of PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis. Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability. Hands on experience of Risk Management process as per ISO 14971 Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies. Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams. Preferred Skills: Sound knowledge on complaint handling process of medical devices will be an added advantage Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have). Good understanding of FDA 21CFR Part 822 / 820 (Good to have) Travel Percentage: None

HCLTECH is conducting a Direct Walk-in Drive in the Medical Devices sector, hashtag#HCLTECH hashtag#Megadrive hashtag#Hyderabad hashtag#on #25th hashtag#May #2025 for hashtag#PMSAnalyst hashtag#ComplaintHandling hashtag#MedicalDomain hashtag#BtechMechanical HCLTech is seeking candidates for the role of Compliance Engineer in the Medical Devices sector in Hyderabad. COntact Person --Divya /Joy /Jenifer **Address:** Sy.No .30,34,35 & 38, Avinash Hitech City2 Society Gachibowli Village, Serillimgampally Mandal, H-01B, Cafeteria, Phoenix Avance Sez Internal Rd, Siddiq Nagar, HITEC City, Hyderabad, Telangana 500081, India. **Job Details:** - **Position:** PMS Service Medical Devices Complaints Handling - **Experience:** 0 to 1 years in the Medical domain - **Location:** Hyderabad - **Education:** B.E./B. Tech (Mechanical) - Immediate joiners & 30 days' notice period required **Job Description:** Managing customer complaints related to medical devices, ensuring regulatory compliance and operational efficiency. **Roles and Responsibilities:** - Thorough evaluation and investigation of complaints - Effective collaboration with cross-functional teams - Maintenance of regulatory compliance standards - Detailed reporting and clear communication **Skills Required:** - Freshers to 1 year experience in Medical Devices complaints handling or PMS - Knowledge of global medical device regulations - Strong mechanical problem analysis skills - Excellent written and verbal communication abilities **Interested candidates** can attend the interview and consider this as a call letter. hashtag#apply : https://lnkd.in/gtSxtBBn **Contact Person:** Divya sri (mandru.divyasri@hcltech.com) / Joy /Jenifer **Important Guidelines:** - Only Btech Mechanical candidates are eligible for this Mega drive - Candidates should have all the marks sheet . -

HCLTECH is conducting a Direct Walk-in Drive in the Medical Devices sector, hashtag#HCLTECH hashtag#Megadrive hashtag#Hyderabad hashtag#on #25th hashtag#May #2025 for hashtag#PMSAnalyst hashtag#ComplaintHandling hashtag#MedicalDomain hashtag#BtechMechanical HCLTech is seeking candidates for the role of Compliance Engineer in the Medical Devices sector in Hyderabad. **Address:** Sy.No .30,34,35 & 38, Avinash Hitech City2 Society Gachibowli Village, Serillimgampally Mandal, H-01B, Cafeteria, Phoenix Avance Sez Internal Rd, Siddiq Nagar, HITEC City, Hyderabad, Telangana 500081, India. **Job Details:** - **Position:** PMS Service Medical Devices Complaints Handling - **Experience:** 0 to 1 years in the Medical domain - **Location:** Hyderabad - **Education:** B.E./B. Tech (Mechanical) - Immediate joiners & 30 days' notice period required **Job Description:** Managing customer complaints related to medical devices, ensuring regulatory compliance and operational efficiency. **Roles and Responsibilities:** - Thorough evaluation and investigation of complaints - Effective collaboration with cross-functional teams - Maintenance of regulatory compliance standards - Detailed reporting and clear communication **Skills Required:** - Freshers to 1 year experience in Medical Devices complaints handling or PMS - Knowledge of global medical device regulations - Strong mechanical problem analysis skills - Excellent written and verbal communication abilities **Interested candidates** can attend the interview and consider this as a call letter. hashtag#apply : https://lnkd.in/gtSxtBBn **Contact Person:** Divya sri (mandru.divyasri@hcltech.com) / Joy /Jenifer **Important Guidelines:** - Only Btech Mechanical candidates are eligible for this Mega drive - Candidates should have all the marks sheet . -

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Job Summary We are looking for a detail-oriented and experienced Quality Control Engineer to join our manufacturing team. The ideal candidate will be responsible for implementing and overseeing quality control processes, ensuring all products meet national and international medical device standards, and working closely with production and R&D to resolve quality issues. Key Responsibilities Conduct in-process and final quality inspections for medical devices in accordance with GMP and ISO 13485 standards. Develop and maintain QC protocols, SOPs, and inspection reports. Ensure compliance with regulatory requirements such as CDSCO, MDR 2017, ISO 13485, and CE. Perform root cause analysis and corrective/preventive action (CAPA) for quality issues and non-conformities. Liaise with production, QA, and R&D teams to address quality-related challenges. Monitor and analyze data from incoming raw materials, in-process controls, and finished goods. Maintain proper documentation and assist in internal/external audits. Qualifications & Skills Bachelor's degree in Engineering (preferably in Biomedical, Mechanical, or Industrial Engineering). 25 years of experience in a QC role within the medical device or pharmaceutical industry. Strong knowledge of ISO 13485, QMS, GMP, and applicable regulatory standards. Hands-on experience with measurement tools (e.g., Vernier calipers, micrometers, leak testers). Proficiency in documentation and data analysis. Familiarity with cleanroom protocols and sterilization validation is a plus.

1. Experience in manufacturing operations 2. 6+ years experience in a supervisory capacity and leadership roles 3. Bachelors degree in production management, Engineering, or a related field. 4. Excellent project management skills 5. Experience in creating procedures and monitoring product servicing activities 6. Experience in production and quality control as per ISO 13485 7. Decent understanding of medical device manufacturing processes 8. Proven track record of successfully training employees in productivity and safety 9. Ability to coach and mentor employees on a one-on-one basis as well as a group 10. Knowledge of project management principles and practices 11. Knowledge of business and management principles and practices

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS applications Proficiency in developing API, Web, and Mobile (iOS and Android) test automation using tools like Cypress, API automation, Appium, TestNG, and Jenkins Familiarity with agile development methodologies and tools like JAMA, JIRA, and GIT Strong knowledge of HIPAA, ISO13485, and IEC62304 is highly desired Roles and Responsibilities: Collaborate with cross-functional teams to define use cases, write test plans, and execute test cases for medical devices Analyze product requirements and design appropriate test strategies and verification plans Ensure compliance with regulatory standards in coordination with the regulatory team Develop and implement automated test solutions to enhance product quality, robustness, compliance, and user satisfaction Identify, document, and track defects using issue tracking software (JIRA) Continuously improve testing processes and contribute to product lifecycle management Skills : - Cypress, API automation, Appium, TestNG, Jenkins, JIRA, JAMA, GIT, SaaS applications, HIPAA, ISO 13485, IEC 62304, software testing, medical device testing, test automation, defect tracking, agile methodology