133 Iso 13485 Jobs - Page 3

KEY RESPONSIBILITIES: Delegating and directing service tasks, monitoring the progress of current projects, and managing service team members to ensure the team's objectives and sales goals are met. Handling customer complaints or concerns quickly and professionally to maintain good customer relationships and ensure repeat customers. Assisting with or performing administrative tasks, such as managing and updating invoices, processing new orders, and tracking inventory. Setting up and maintaining a service desk and evaluating its efficiency. Resolving service desk problems and improving service methods to increase the service desk's productivity and customer service. Monitoring department issues and client complaints to create methods to lessen recurring issues. Ensuring First Response Time, Complaint Handle Time, First Contact resolution are within the prescribed limits as directed by the Management. Auditing work and customer service to ensure the company's high standards, efficiency, and productivity goals are met. Ensuring Quality Standards as per ISO 9001, ISO 13485, CE MDD/MDR, USFDA, CDSCO standards and any other applicable standards and systems. Maintaining strong relationships with manufacturers, dealers, and sales representatives. Helping to train new employees in company procedures. Maintaining a strong working knowledge of industry regulations, restrictions, and laws, ensuring the company's adherence to these regulations, and remaining current on the industry's standards and new innovations, materials, tools, and processes.

A Day in the Life Quality Engineer II for risk management & PSUR activities support for CST OU A Day in the Life Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards. Responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. Must Have Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements. Subject matter expert in risk management for designated medical device products or platforms. Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes. Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements. Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports. Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities. Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance. Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR. Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis. Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies. Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Provide Quality support to facilitate resolution of product complaints and/or safety issues Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab) Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on complaints analysis, Post market surveillance, Design Controls for Medical Devices. Minimum Qualification B E or B. Tech in Mechanical/Biomedical Engineering Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience Key Technical Competencies Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Good verbal and written communication skills Understanding of post-market surveillance processes and adverse event reporting. Knowledge of risk management principles and hazard analysis in the context of medical devices. Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 9001 Internal Auditor / Lead Auditor Certification ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. 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

Description & Requirements Introduction: A Career at HARMAN Digital Transformation Solutions (DTS) We re a global, multi-disciplinary team that s putting the innovative power of technology to work and transforming tomorrow. At HARMAN DTS, you solve challenges by creating innovative solutions. Combine the physical and digital, making technology a more dynamic force to solve challenges and serve humanity s needs Work at the convergence of cross channel UX, cloud, insightful data, IoT and mobility Empower companies to create new digital business models, enter new markets, and improve customer experiences About the Role Bachelor s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality. . What You Will Do Qualified to assess patient safety risks via one of the following: Medical Doctor with related device experience Engineer who has achieved IBHRE or NASPE Exam certification At least 5 years of clinical field experience in the past 15 years. The relevant field experience could include the following: o Nurse o Field Personnel such as: Clinical Specialist, Technical Field Educator, Field o Clinical Engineer o Technical Services (cardiac products) Personnel with at least 5 years of previous clinical experience related to cardiac therapy products. What You Need Advanced degree in Engineering or Science Proven understanding of reliability engineering principles Strong understanding of and experience in the application of statistics, including experience with Minitab Experience in a highly regulated industry, preferably implantable medical devices Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc. Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA) Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms CRE Certified Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices What Makes You Eligible You hold a Bachelor s or Master s degree in Computer Science, Engineering, or a related technical field. Demonstrate strong problem-solving abilities and a deep understanding of backend system design and architecture. You re passionate about clean code , continuous learning, and sharing knowledge with teammates. What We Offer Access to employee discounts on world class HARMAN/Samsung products (JBL, Harman Kardon, AKG etc.) Professional development opportunities through HARMAN University s business and leadership academies. Flexible work schedule with a culture encouraging work life integration and collaboration in a global environment. An inclusive and diverse work environment that fosters and encourages professional and personal development. Tuition reimbursement. Be Brilliant employee recognition and rewards program. You Belong Here HARMAN is committed to making every employee feel welcomed, valued, and empowered. No matter what role you play, we encourage you to share your ideas, voice your distinct perspective, and bring your whole self with you - all within a support-minded culture that celebrates what makes each of us unique. We also recognize that learning is a lifelong pursuit and want you to flourish. We proudly offer added opportunities for training, development, and continuing education, further empowering you to live the career you want. About HARMAN: Where Innovation Unleashes Next-Level Technology Ever since the 1920s, we ve been amplifying the sense of sound. Today, that legacy endures, with integrated technology platforms that make the world smarter, safer, and more connected. Across automotive, lifestyle, and digital transformation solutions, we create innovative technologies that turn ordinary moments into extraordinary experiences. Our renowned automotive and lifestyle solutions can be found everywhere, from the music we play in our cars and homes to venues that feature today s most sought-after performers, while our digital transformation solutions serve humanity by addressing the world s ever-evolving needs and demands. Marketing our award-winning portfolio under 16 iconic brands, such as JBL, Mark Levinson, and Revel, we set ourselves apart by exceeding the highest engineering and design standards for our customers, our partners and each other. If you re ready to innovate and do work that makes a lasting impact, join our talent community today ! Please be aware that HARMAN recruiters will always communicate with you from an @harman.com email address. We will never ask for payments, banking, credit card, personal financial information or access to your LinkedIn/email account during the screening, interview, or recruitment process. If you are asked for .

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. Job Description To support our extraordinary teams who build great products and contribute to our growth, we re looking to add an Engineer - Quality Compliance located in Bangalore. What a typical day looks like: Should develop and initiates standards and methods for inspection, testing and evaluation. Will be responsible to devise sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data. Will develop and implements methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility. Responsible to direct workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability. Responsible for compiles and writes training material and conducts training sessions on quality control activities. Involved in preparing Internal Audits plan. Performing internal audits to verify compliance and conformance to all regulatory and Quality & EHS systems requirements, including both Customer and Flex mandated. Will be supporting Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues. Responsible to assures data availability and integrity for all quality related data. Consolidates and reports quality results. Will be responsible to initiate corrective action requests as needed and tracks to satisfactory completion. To give support for the development and implementation of quality audits. Responsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products. Responsible to carry out designs and implementation methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment. Responsible to study the reports and returned products and recommends corrective action. Responsible to establishes program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilities. To officially accept product, process and equipment qualifications. Provides liaison to various regulatory bodies The experience we re looking to add to our team Diploma / BE /B.Tech graduates with 4+ years of relevant work experience Work Experience in establishing Internal Quality & EHS Systems Manuals and Level 1 Procedures, Manufacturing / Service work instructions, Forms. Preferred experience in implementation and ensuring effectiveness of the applicable Regulations, Standards, Policies, Directives and Level 1 Procedures in the organization. Internal auditor certificate for QMS & EHS Management system (ISO 9001, ISO 14001, ISO 45001, TL, ISO 13485) Should possess training/Knowledge on Regulations and IDE and Clinical trials applications in accordance with MDD Annex X, ISO 14155 standard. Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards. Should have an excellent understanding and practical application of medical device quality system regulations, e.g., 21 CFR 820, ISO 13485 and ISO 14971 What you ll receive for the great work you provide : Health insurance PTO #RA01 Job Category Quality Flex pays for all costs associated with the application, interview or offer process, a candidate will not be asked for any payment related to these costs. Flex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: accessibility@flex.com . Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.

Job Description Summary Job Summary: The Product Safety and Standards Compliance Engineer will be responsible for ensuring that all medical devices and related products adhere to applicable safety standards and regulations. The role involves conducting thorough safety assessments, identifying potential hazards, collaborating with design teams to mitigate risks, and maintaining compliance throughout the product lifecycle. This position is crucial for prioritizing patient safety and ensuring regulatory adherence within the healthcare industry. . Job Description Key Responsibilities: Risk Assessment and Hazard Identification: Perform detailed safety analyses on new and existing medical devices to identify potential hazards and assess their associated risks using methodologies like Failure Mode and Effect Analysis (FMEA) and other risk management tools. Conduct thorough reviews of product designs, materials, and manufacturing processes to identify potential safety concerns. Compliance with Regulatory Standards: Stay updated on relevant international and national healthcare regulations (e.g., FDA, ISO 13485, IEC 60601) and ensure products comply with all applicable standards. Develop and maintain compliance documentation, including technical files, risk management plans, and product safety reports. Design Input and Collaboration: Work closely with product development teams to integrate safety considerations into product designs from the early stages of development. Provide technical expertise on safety standards and regulations to engineering teams to ensure safe product design and implementation. Testing and Certification: Oversee product testing and certification processes to verify compliance with safety standards, including collaborating with external testing laboratories. Analyze test results and interpret data to identify potential safety concerns. Incident Investigation and Corrective Action: Investigate reported product safety incidents, analyze root causes, and implement appropriate corrective actions to prevent recurrence. Monitor post-market surveillance data to identify safety trends and take proactive measures to address potential issues. Training and Awareness: Conduct training programs for cross-functional teams on product safety principles, regulatory requirements, and risk management practices. Required Skills and Qualifications: Bachelors degree in Biomedical Engineering, Mechanical Engineering, or a related field. Strong understanding of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601). Expertise in risk management methodologies and tools. Excellent analytical and problem-solving skills. Strong communication and collaboration skills to work effectively with cross-functional teams. Experience with product development lifecycle and design control processes. Ability to stay updated with emerging safety standards and regulatory changes. Preferred Qualifications: Master s degree in a related field. Certification in quality management systems or risk management. Prior experience in a similar role within the healthcare or medical device industry. Working Conditions: Office environment with occasional travel to manufacturing sites, testing laboratories, and industry conferences. Ability to work in a fast-paced and dynamic environment with strict regulatory timelines. Inclusion and Diversity . Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-Hybrid #LI-MP2 #EveryRoleIsVital Relocation Assistance Provided: Yes

Role Description: We are seeking a Quality Assurance (QA) Manager to oversee and ensure compliance with quality standards, regulatory requirements, and Good Manufacturing Practices (GMP). The role requires strong expertise in Quality Management Systems (QMS), audits, and process improvements. Designation: QA Manager Department: Quality Assurance Experience: Minimum 7 years in Medical Device/Pharma/Life Sciences Industry Regulatory Experience: Minimum 3-5 years in ISO 13485, MDSAP, US FDA, GMP Compliance Industry/Background: Medical Device / Pharma / Lifesciences Industry Qualification: B. Pharm / M. Pharm / M.Sc. Life Science / B.Tech Biotechnology / Related Field Employment Status: Permanent Workplace Type: On-site Minimum Requirements: Strong knowledge of ISO 13485, QMS, MDSAP, and US FDA guidelines. Experience in conducting and facing regulatory audits (MDSAP, FDA, ISO). Expertise in quality documentation, deviation handling, and CAPA. Experience in risk management, validation, and qualification processes. Ability to lead and coordinate internal and external audits. Experience in handling change control, non-conformances, and product recalls. Strong communication and leadership skills. Roles and Responsibilities: Develop and implement Quality Management Systems (QMS) as per regulatory guidelines. Ensure compliance with GMP, US FDA, MDSAP, and ISO 13485. Conduct and lead internal audits, external audits, and supplier audits. Oversee CAPA, deviations, complaints, and non-conformances. Ensure proper documentation and timely submission of regulatory reports. Provide training and guidance to teams on quality procedures. Collaborate with cross-functional teams to ensure product quality and compliance. Support regulatory filings and post-approval compliance activities.|

Develop and execute the product strategy for Drug Delivery Single Use Bags and Devices. Work closely with R&D, regulatory, and sales teams to ensure successful product development. Conduct market analysis to identify opportunities for new products and improvements. Define product specifications, pricing, and positioning. Manage product lifecycle, from conception to commercialization. Oversee regulatory compliance and quality standards. Develop sales training materials and marketing strategies. Build relationships with key industry experts and healthcare professionals. Qualifications & Requirements: Bachelor s/Master s degree in Biomedical Engineering, Biotechnology, or Life Sciences. 5+ years of experience in product management within the medical device industry. Expertise in Drug Delivery Single Use Bags and Devices. Strong knowledge of ISO 13485, FDA, and MDR regulations. Excellent project management and leadership skills.

We are seeking a Quality Control (QC) Manager to oversee product testing, quality analysis, and compliance with regulatory standards. The QC Manager will be responsible for ensuring the integrity of raw materials, in-process materials, and finished products. Designation: QC Manager Department: Quality Control Experience: Minimum 7 years in Medical Device/Pharma/Life Sciences Industry Regulatory Experience: Minimum 3-5 years in GMP, US FDA, ISO 13485, and Analytical Testing Industry/Background: Medical Device / Pharma / Lifesciences Industry Qualification: B. Pharm / M. Pharm / M.Sc. Life Science / B.Tech Biotechnology / Related Field Employment Status: Permanent Workplace Type: On-site Minimum Requirements: Strong knowledge of analytical techniques, stability studies, and microbiology testing. Experience in handling QC documentation, test reports, and specifications. Proficiency in GMP, ISO 13485, US FDA, and MDSAP compliance. Expertise in using HPLC, GC, UV, and other analytical instruments. Experience in raw material, in-process, and finished product testing. Strong knowledge of deviation handling, OOS investigations, and CAPA. Ability to lead a QC laboratory and ensure smooth functioning of testing operations. Roles and Responsibilities: Oversee quality control operations and ensure compliance with regulatory standards. Ensure proper testing and validation of raw materials, in-process, and finished products. Review and approve test reports, analytical data, and quality records. Monitor and maintain stability studies and analytical testing procedures. Conduct investigations for out-of-specification (OOS) results and deviations. Ensure the calibration and maintenance of laboratory instruments. Coordinate with cross-functional teams to ensure product quality. Support regulatory submissions and participate in regulatory inspections.

We are seeking a Design Engineer with a Mechanical Engineering background to work on product design and development. The ideal candidate should have expertise in SolidWorks and experience in designing components for the medical device, biotech, or life sciences industry. Designation: Design Engineer Department: Product Design & Development Experience: Minimum 2 years in design engineering Industry/Background: Mechanical / Medical Device / Pharma / Lifesciences Industry Software Expertise: SolidWorks (mandatory), AutoCAD (preferred) Qualification: B.E / B.Tech Mechanical Engineering or related field Employment Status: Permanent Workplace Type: On-site Minimum Requirements: Minimum 2 years of experience in product design and development. Strong proficiency in SolidWorks for 3D modeling, drafting, and assembly design. Experience in designing plastic and metal components, sheet metal, and machined parts. Knowledge of GD&T, tolerance analysis, and material selection. Understanding of manufacturing processes, prototyping, and DFM/DFA principles. Ability to read and interpret engineering drawings. Exposure to ISO 13485 and medical device design standards is a plus. Strong problem-solving and analytical skills. Good communication and teamwork skills. Roles and Responsibilities: Design and develop medical devices and accessories as per industry standards. Create and modify 3D models, technical drawings, and assemblies using SolidWorks. Conduct DFM (Design for Manufacturing) and DFA (Design for Assembly) analysis. Work closely with R&D, production, and quality teams to ensure product feasibility. Prepare technical documentation, BOMs, and design reports. Collaborate with vendors and suppliers for prototyping and manufacturing feasibility. Support testing, validation, and regulatory documentation for product approvals. Ensure compliance with ISO 13485 and regulatory standards for medical devices.

Job Description Job Title: Risk Management SME Medical Devices Location: Pune Employment Type: Full-Time Experience: 10+ Years Industry: Medical Devices Job Summary: We are seeking a highly experienced Risk Management Subject Matter Expert (SME) with a strong background in medical device regulatory and quality systems. The ideal candidate will have 10+ years of experience working with cross-functional teams including RD, Regulatory Affairs, and Design Quality to ensure product compliance throughout the lifecycle. This role requires deep knowledge of risk management, global regulatory requirements (EU MDR, US FDA 510(k)), and relevant medical device standards. Key Responsibilities: Lead and execute risk management activities throughout the product lifecycle. Review and simplify Risk Management Files (RMF), Risk Mitigation Measures (RMM), BRDs, DHFs, traceability matrices, design requirements, and IFUs. Ensure compliance with global medical device regulations and standards (ISO 14971, ISO 13485, IEC 60601-1, IEC 62366-1, ISO 10993-1, MEDDEV 2.7/4). Collaborate with RD and Quality teams to validate design inputs (Usability, Safety, Reliability, etc.). Oversee and contribute to Verification Validation (VV) activities. Manage quality plans across all stages of the product lifecycle and ensure execution oversight. Conduct technical assessments and post-market analysis on product performance. Provide analytics and statistical reporting for post-market surveillance. Act as the primary quality representative in project teams ensuring design compliance at every milestone. Requirements: Degree in Mechanical/Electrical Engineering, Applied Sciences, or related field. 10+ years of experience in medical device industry focusing on risk management and regulatory compliance. Expertise in quality management systems (QMS) like ISO 13485, MDSAP, and EU MDR. Hands-on experience with quality and product development systems. Strong communication and cross-functional collaboration skills. Proven ability to drive quality excellence and compliance. Job Overview Posted date : 27 Jun 2025 Location : Any Location, India Experience : 10+ years

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Post-market surveillance involves collecting, analyzing, and interpreting data related to medical device use in real-world clinical settings. The Post Market Surveillance Associate will be responsible for drafting, analyzing and issuance of Periodic Safety Update Reports in accordance with EU and other country Regulations. Essential Duties and Responsibilities: Drafting and issuance of Post Market Surveillance Plans as per the requirement. Collect and analyze the required data and Draft the Periodic Safety Update Reports and Post Market Surveillance Reports. Evaluate the emerging risks from the data analyzed. Working with the stakeholders to address the issues, roadblocks keeping the process smooth. Timely issuance of PMS Documents. To work with the team to streamline the PMS process. Also support the complaint process by owing and processing quality complaint as per applicable procedures. Author and submit applicable regulatory reports (MDR, MIR, etc) to competent authorities when deemed required. Performs other duties as needed and assigned. Qualifications: Excellent verbal and written communication skills. Analytical approach to problem solving. Ability to handle and manage workload independently. Education and/or Experience: bachelors Degree - Preferred: engineering, nursing, biomedical, life science, or equivalent (S.T.E.M.). Prior experience (2+ years) with PMS requirements (PMSP, PSUR) in medical device industry. Experience with current U.S. FDA, EUMDR, MDD, ISO 13485, ISO9001, MDSAP and/or CMDR regulations, standards, and guidance documents (Preferred). Reasonable Accommodation

Role & responsibilities Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Good Communicator & writing skills. Social Media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Establish rapport and liaison with Regulatory bodies and seek advance information on legal/regulatory introduction/amendments. Connects and actively interacts with Medical Device Industry forums. Generates proposals in compliance with Notified /Accreditation Body requirements and/or product sector requirements. Maintains accurate records of all sales and prospecting activities including sales calls, presentations, closed sales, and follow-up. Adheres to internal standards, policies and procedures.

Role & responsibilities Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Social Media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Mandatory skills: Minimum 5 years of experience handling Medical Devices sales, Certification body experience, team management exposure.

Role & responsibilities Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Social Media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Mandatory skills: Minimum 5 years of experience handling Medical Devices sales, Certification body experience, team management exposure.

Coaching delivery teams on the quality management system, tailoring to create project specific processes, quality goals and plans to achieve project objectives Reviewing delivery artefacts for compliance and conducting delivery reviews Help in planning and conducting internal audits including support departments Handling customer complaints and ensuring completion of customer satisfaction surveys Facilitate continual improvement and break through process improvements Support in data analysis and use of statistics in creating baselines and accessing stability of processes Support in management reviews and reporting Ensure compliance to ISO 9001, ISO 13485 and CMMI L5 Should have at least 2 years experience in software development and testing activities and minimum of 3 years in software quality assurance activities Should have completed ISO 9001 implementation or lead auditor certification Would be good have CMMI DEV Implementation experience and Certified in Basic statistics such as Six Sigma Green belt. Nice to have the following certificate: CMMI DEV or SVC associate certificate AS9100 / ISO 13485 / Automotive Safety Certificates Basic understanding of AI / ML Experience in process definition and high maturity practices Participation in CMMI appraisals

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. . Job Description Roles and Responsibilities GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Required Qualifications For roles outside of the USA- This role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). For roles in USA - Bachelors degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)). Desired Characteristics Experience in Quality Management System Manufacturing QMS Exposure Experience with ISO 13485 Experience with FDA CAPA, process improvement Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. . Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https: / / www.ge.com / careers / fraud Relocation Assistance Provided: No

ql-editor "> Head, Lateral Flow Assay (LFA) Team Roles & Responsibilities Direct the end-to-end development of quantitative/qualitative lateral flow assays (LFAs) with a strong emphasis on colloidal gold-based technologies, from concept through commercial launch. Develop and implement project plans, ensuring timely delivery of milestones and final products to the commercial market. Build, mentor, and manage a multidisciplinary team of scientists, engineers, and technicians; foster a collaborative environment that encourages innovation and professional growth. Coordinate with manufacturing, quality assurance, and regulatory teams to ensure robust assay design, process optimization, and regulatory compliance. Guide assay optimization, troubleshooting, and validation, with a focus on enhancing sensitivity, specificity, and reproducibility of quantitative LFA platforms. Allocate resources efficiently, manage budgets, and ensure procurement of critical raw materials and reagents for assay development. Provide regular project updates to senior management and stakeholders; prepare technical reports and presentations as needed. Drive process improvements and implement best practices for assay development, scale-up, and transfer to manufacturing. Identify project risks and develop contingency plans to ensure on-time delivery and high-quality outcomes. Candidate Qualifications Education: PhD or Master s degree in Biochemistry, Biotechnology, Analytical Chemistry, or a related field. Experience: Minimum 8+ years of hands-on experience in lateral flow assay development, with a proven track record of delivering quantitative colloidal gold-based products to the commercial market. Experience with fluorescence-based assays is a plus. Regulatory & Quality Understanding: Familiarity with IVD regulatory requirements (CDSCO and CE-IVD), quality management systems (e.g., ISO 13485), and design transfer to manufacturing. Communication: Excellent verbal and written communication skills; ability to convey complex technical concepts to diverse audiences. Problem-Solving: Strong analytical and troubleshooting skills, with the ability to resolve technical and operational challenges quickly and effectively. Commercial Acumen: Experience working with cross-functional teams to bring diagnostic products from R&D through to successful market launch.

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At HemoCue, one of Danaher s 15+ operating companies, our work saves lives and we re all united by a shared commitment to innovate for tangible impact. You ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflows. For more than four decades we ve been advancing what s possible at the point of care. HemoCue offers point-of-care testing for hemoglobin, glucose and HbA1c as well as total and differential white blood cell count. The Development Engineer, Firmware at HemoCue is responsible for documentation and test of design changes within the Sustaining Engineering department, mainly firmware changes. This position is part of the R&D-team located in Bangalore and will be on-site. At HemoCue, our vision is to do things easier, to do things better, and to do them right. You will be a part of the Sustaining Engineering and report to the Director of Sustaining Engineering, (located in at headquarter in Sweden). You will be responsible for planning, design, implementation, documentation, and test of software modules. If you thrive in a fast-paced environment, enjoy working independently but also cross-functionally and want to work to build a world-class R&D organization read on. In this role, you will have the opportunity to: Perform product support activities for current products, primary instrument activities Cross-functional work with operations department and/or subcontractor by solving problems, coordinating, verifying and approving changes to HemoCue products Execute and/or participate in product lifecycle activities, such as CAPAs, engineering change orders, cost down activities and general sustaining engineering activities The essential requirements of the job include: University degree: Master of Science, Bachelor of Science or Engineering or equivalent work experience within Software and at least 3 years of work experience Knowledge of software development tools, design patterns and programming paradigms. Experience of C and C++ development on embedded systems (ARM microcontrollers). Knowledge of analog and digital electronics Your main communication language will be English Knowledge about ISO 13485, QSReg and Design Control It would be a plus if you also possess previous experience in: Experience from product development of medical devices Experience from design changes for medical devices Cybersecurity Join a winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.QMS Management: Take ownership of QMS documentation, ensuring it's current, accurate, and accessible. Regulatory Compliance: Apply strong knowledge of FDA Quality System Regulation (QSR), ISO 13485, and EU Medical Device Regulation (EUMDR) to all quality processes. Design History Files (DHFs): Manage and maintain Design History Files, ensuring completeness and compliance throughout the product development lifecycle. CAPA Management: Lead and support Corrective and Preventive Actions (CAPAs), from initiation and investigation to implementation and verification of effectiveness. Audits: Facilitate and support internal and external audits (e.g., regulatory inspections, notified body audits), ensuring readiness and effective follow-up on findings. Supplier Quality: Oversee supplier qualification, monitoring, and quality agreements to ensure high standards across our supply chain. Training & Calibration: Manage and track quality-related training programs and ensure timely calibration of essential equipment. Cross-functional Collaboration: Partner with teams like Product Development to integrate quality requirements early in the design process and support overall quality improvements. Regulatory Submissions: Provide critical support for regulatory submissions, ensuring all necessary quality documentation is complete and accurate.

Electronics Engineer Medical Device Product Development Location: Pune, Maharashtra, India Employment Type: Full-Time Experience Required: 57 years About InnoIQ Engineering InnoIQ Engineering, a subsidiary of B&W Engineering und Datensysteme GmbH (Germany), excels in research, design, and development of precision medical devices. From concept through regulatory compliance and production support, we deliver innovative, high-quality solutions for global clients in the medical device space. Role Overview As a key member of our team, youll lead electronics design for new medical devicesfrom schematic capture and PCB layout using Altium Designer , to component selection and prototype validation. Youll ensure full compliance with standards like IEC 60601, ISO 13485/14971, IEC 62366, and FDA 21 CFR 820. • Key Responsibilities End-to-End Electronics Design Drive schematic design and PCB layout from scratch using Altium Designer , including creation of symbols, footprints, library management, and templates. Perform detailed multi-layer board design with emphasis on signal integrity, EMI/EMC, thermal performance, DRC/ERC, and DFM/DFT. Components & Libraries Build and maintain Altium library assets (schematics, PCB footprints, 3D models), and manage lifecycle with traceability for compliance. Medical-Grade Standards & Design Control Design compliant with IEC 60601 (11 & 12), ISO 13485, ISO 14971, IEC 62366, and FDA 21 CFR 820 processes. Support DFMEA/risk management and maintain complete Design History File (DHF). Prototype & Test Develop and execute test setups for verification/validation, including electrical safety, EMC, and performance benchmarks. Debug via oscilloscopes, spectrum analyzers, and logic analyzers through first builds and pilot runs. Cross-Functional Collaboration Align with firmware, mechanical, QA, procurement, and manufacturing teams to ensure seamless integration and production readiness. Assist in NPI, including PCB prototype coordination, pilot transfers, and documentation handoff. Documentation & Leadership Prepare engineering documents: design specs, BOMs, assembly/test procedures, test plans, and validation reports. Lead schematic/PCB design reviews and mentor junior engineers. Required Skills & Experience Bachelors or Masters in Electronics/Electrical/Biomedical Engineering. 57 years in electronics design, ideally in medical-device or similarly regulated sectors. Proficiency in Altium Designer (schematic capture, multi-layer PCB layout, library and template creation). Solid knowledge of analog/digital circuit design, power distribution, sensor/MCU interfaces, high-speed considerations. Hands-on testing experience with oscilloscopes, logic analyzers, EMC analyzers. Understanding of medical standards: IEC 60601 series, ISO 13485/14971, IEC 62366, FDA 21 CFR 820. Excellent documentation skills, attention to detail, and teamwork orientation. Desired (Plus) Skills Experience in signal integrity, EMC/EMI mitigation, or high-speed board designs. Familiarity with embedded firmware collaboration or sensor-driven system design. DFMEA, obsolescence planning, and life-cycle management proficiency. Knowledge of RoHS, IPC standards, and medical usability engineering. Benefits Competitive compensation, performance bonuses Medical insurance and wellness initiatives Career growth, training, and certification support Collaborative global environment shaping medical-grade technology How to Apply Send your CV and cover letter detailing Altium-based schematic & PCB design experience in medical devices to career@innoiq.com with subject: Electronics Engineer Medical Device, Pune (Altium)

Job Title: Embedded Software Engineer Medical Device Technology Location: Pune Department: Engineering / Embedded Systems Employment Type: Full Time Company Overview: InnoIQ Engineering , a subsidiary of B&W Engineering und Datensysteme GmbH, Germany , is a leading company specializing in the research, design, and development of innovative medical devices . With a strong focus on precision, quality, and customer-centric solutions , we collaborate with global clients to bring advanced medical technologies to life. From concept design and prototyping to production support , we offer comprehensive engineering solutions tailored for the medical device industry . Position Summary: We are seeking a passionate and detail-oriented Embedded Software Engineer to join our growing engineering team. You will play a critical role in the development of embedded software solutions for cutting-edge medical devices , ensuring compliance with regulatory standards and delivering high-quality products that positively impact patient care. Key Responsibilities: Design, develop, test, and maintain embedded software for medical devices Collaborate with cross-functional teams including electronics, mechanical, and system engineers Write efficient, reliable, and reusable code in C/C++ for embedded platforms Contribute to software architecture and system integration for real-time embedded systems Conduct software verification, validation, and unit testing in accordance with IEC 62304 Support design documentation and risk management activities per ISO 13485 and ISO 14971 Debug hardware/software integration issues using appropriate tools and methods Participate in design reviews, code reviews, and continuous improvement activities Required Qualifications: Bachelors or Masters degree in Electronics Engineering , Computer Engineering , Embedded Systems , or related field 2+ years of experience in embedded software development , preferably in the medical device domain Proficiency in C/C++ programming and real-time embedded systems Experience with microcontrollers , RTOS , and hardware-software interfacing Strong understanding of software development life cycle in regulated environments Knowledge of medical standards such as IEC 62304 , ISO 13485 , and ISO 14971 Good problem-solving skills and attention to detail Proficient in written and spoken English Preferred Qualifications: Experience with wireless communication protocols BLE, NFC Familiarity with version control systems Git and tools like Jira, Confluence Experience in developing software under Agile or V-model process Why Join Us? Be part of a global team developing life-enhancing medical technologies Work in a culture that values innovation , precision , and continuous learning Opportunities to grow in a fast-paced , quality-driven , and regulatory-compliant environment Exposure to international projects and collaboration with leading medical device companies

Key Deliverables: Provide quality oversight across design, validation, and lifecycle of combination products Support regulatory submissions, audits, and RTQ responses Ensure compliance with global standards including ISO 13485 and 21 CFR Lead quality process improvements for device, labeling, and packaging Role Responsibilities: Act as single point of quality contact for final product activities Review risk management, HFE documentation, and design controls Train teams on quality and regulatory requirements for combination products Manage complaint investigations and site transfer quality activities

Job Purpose: Maintain compliance to Quality Management System to deliver consistent quality medical devices to fulfil future strategy of Cipla. To Lead and establish Quality Management System for medical devices as per EU Regulatory requirements, CDSCO and ISO 13485 requirements and develop and implement documentation such as SOPs, Quality manual etc. to define the framework. Monitor effective implementation of Quality System across function and appraise Management Representative. Responsible for monitoring metrics/KPI for medical devices starting from design, manufacturing, postproduction. Compile data for management review meetings. Responsible for coordinating with cross functional team for internal / external audit compliance for ISO and CE marking Responsible for surveillance of regulatory guidance/ standards applicable to medical devices in the respective geographies in which Cipla products are distributed. Key Accountabilities: Develop, establish and maintain the QMS for medical devices according to EU MDR and ISO 13485 requirements. Surveillance of new/updated regulatory guidance/ ISO standards applicable to medical devices as per Ciplas product portfolio to ensure compliance to latest regulations. Surveillance of EU noncompliance reports / CDSCO / USFDA etc that are applicable to medical devices manufactured by Cipla to enable continuous improvement. Execution of Quality Management Review meeting for Medical devices and implementation of actions derived in the QMR meetings. Conduct audit of Vendors / contract manufacturers/ outsourced activities associated with medical device manufacturing/ servicing/ testing/ distribution. Ensure timely submission of quality documents to fulfil regulatory requirements. Major Activities / Tasks: Develop and establish Management responsibility system as per ISO 13485 and EU MDR Develop and establish design control system for EU market. Develop and establish key performance indicators (KPIs) for monitoring site performance and effectiveness of QMS as per ISO 13485. Prepare SOPs, Quality manual etc.as per ISO 13485/ EU MDR. Responsible to maintain compliance to ISO 13485 by adhering to SOPs and ensuring control and oversight over adherence by respective depts to SOPs. Periodic review of SOPs related to medical devices as per regulatory requirements and update. Arrange training and promote awareness among cross functional teams on ISO 13485 QMS and CE Marking Ensure readiness from QMS standpoint for internal and external audits. Provide guidance and support during internal and external audits examining compliance to EU MDR/ISO 13485 requirements. Co-ordinate with cross functional teams for internal/ external audit compliance. Create library of ISO standards. Review new/upcoming/ draft/ revised/ final regulatory guidance/ ISO standards related to medical devices applicable as per Ciplas product portfolio. Gap assessment of the guidance / standards in comparison to QMS at Cipla and identify suitable actions prior to implementation of the guidance/standard. Monitor implementation of the actions to enable continuous improvement. Schedule quality management review (QMR) meeting for medical devices. Collate data required for the QMR and prepare the presentation on site performance to monitor effectiveness of Quality management system. Appraise management representative regarding critical issues. Monitor implementation of the action plans derived from QMR by coordinating with other cross functional team. Audit of Vendors supplying Medical devices and Invitro diagnostic kits, completing audit documentation and verifying actions taken by the audited site to correct non-conformances observed. Audit of CMOs manufacturing medical devices, completing audit documentation, and verifying actions taken by the audited site to correct non-conformances observed. Audit of outsourced activities related to medical devices manufacturing/ servicing/ testing/ distribution. Coordinate with RA, QA team and Pharmaco vigilance team through emails and phone to enable timely submission of the documents. Major Challenges: Establishing Quality Management System for Medical devices according to EU MDR / ISO 13485 is new for Cipla, hence developing and maintaining it will be a challenge. Cross functional support is key in ensuring adherence to QMS, as challenge is awareness about EU/ ISO 13485 certification requirements is low in cross functional teams such as IPD/ RA/ SCM/FPS/ DSD, Marketing. Same can be overcome by promoting awareness about EU MDR/ISO 13485 requirements at the outset/ from time to time. Engage in Notified bodies audits for ISO and CE marking audits and coordinate with all Cipla teams for audit management. Coordinate with Cipla team for audit compliance. Skills & Knowledge: Educational qualifications: MSc./ MPharm/ if MTech then in Biomedical engineering; Certificate courses/diploma in ISO audits highly welcome Relevant experience: At least 9-10 years of experience in Quality of Medical Devices/IVDs /Implants Experience in regulated market product approvals e.g. US FDA is a high plus

Education : Minimum B.Sc./M.Sc./B. Tech with computer operating Knowledge. Key skills: Knowledge of Medical Device Industries, ISO, CE & Indian Medical device Rules 2017(Drug department). Responsibility : Deep knowledge of ISO 13485 and ability to make necessary modifications as per requirements. Knowledge of EUMDR, Indian MDR and applicable government regulations. Responsible for regulatory affairs activities to assist in regulatory submission. Responsible for Risk Management as per ISO 14971. Responsible for customer complaints and in-house nonconformity. To conduct and maintain records of Internal audits and MRM including quality objectives. To prepare process validation protocol and perform the validation activity. To analyze the process data as per ISO 13485. To ensure that test methods are strictly adhered to, test reports are forwarded to the designated authority.

Education : UG: B Tech in Mechanical, BSc, B. Tech Medical Science, M sc. Key skills: Regulatory Submissions : 510(k), CE Marking, EU MDR 2017/745, US FDA, Indian MDR 2017 Clinical Evaluation Reports (CER) : Development, Literature Reviews, Clinical Data Analysis Risk Management : ISO 14971, Risk Assessments, Risk Mitigation Strategies Post Market Surveillance (PMS) : Data Collection, Reporting, Device Performance Monitoring Post Market Clinical Follow-up (PMCF) : Study Design, Data Analysis, Reporting Regulatory Compliance : US FDA, EU MDR, Indian MDR, ISO 13485 Communication : Cross-functional collaboration, technical writing, regulatory guidance Desired Candidate Profile: Regulatory Affairs Executive with 3-4 years of experience in medical device regulation and compliance. Proficient in preparing and submitting regulatory filings for product approvals, conducting clinical evaluations, managing risk assessments, and ensuring post-market compliance across multiple regions. Experienced in EU MDR 2017/745, US FDA regulations, Indian MDR 2017, and ISO 13485 standards. Proven ability to collaborate with cross-functional teams to meet regulatory requirements and deliver high-quality documentation, including Clinical Evaluation Reports (CER), Post Market Surveillance (PMS) reports, and PMCF studies. Company Profile: One of the Leading manufacturers and suppliers of Orthopedic Implants and instruments, founded in 1987 and having manufacturing unit at Rai Industrial Area, District Sonipat, Haryana and Corporate Office in Phool Bagh, Rampura, New Delhi Near Ashok Park Main Metro Station.