21 Iso 14971 Jobs

Job Description Summary Manages all Quality Assurance activities associated with the product development and product support processes in BD TCI. Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs. Lead evolution and improvement of the product development process, policies and procedures which will enable design teams to respond rapidly to customer needs. Runs multiple projects directly while managing other quality engineering resources running separate projects. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Mainta...

Job Description Summary Manages all Quality Assurance activities associated with the product development and product support processes in BD TCI. Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs. Lead evolution and improvement of the product development process, policies and procedures which will enable design teams to respond rapidly to customer needs. Runs multiple projects directly while managing other quality engineering resources running separate projects. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Mainta...

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 ...

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

Clinisys is a global provider of intelligent diagnostic informatics solutions and expertise designed to redefine the modern laboratory, across healthcare, life sciences, and public health. Millions of diagnostic results and data insights are generated every day using Clinisys platform and cloud-based solutions in over 4,000 laboratories across 39 countries. Our 1,450+ expert professionals, headquartered in Woking, UK and Tucson, Arizona, have a shared mission to enhance the effectiveness of diagnostic workflows in any laboratory or testing environment and keep citizens and communities healthier and safer. Role Description: This role is the quality owner of the product development and lifecyc...

Job Title: Senior R&D Engineer Medical Devices Location: Mumbai, IND Employment type: Part-time Position Summary: We are seeking an experienced R&D Engineer Trainer with 10+ years in the medical device industry to lead the design, development, and optimization of innovative medical technologies. The role involves driving new product development (NPD) from concept through commercialization, ensuring compliance with global regulatory standards, and collaborating cross-functionally to deliver safe, effective, and high-quality medical devices that improve patient outcomes. Key Responsibilities: Lead the design and development of new medical devices, from feasibility studies through product launc...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, 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. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, 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. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, 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. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, 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. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

Job Description Core Skills 15+ years of hands-on software development experience, with 3-5 years in a senior/principal architect role. Proven expertise in C# .NET and/or Java. Flexibility to work across both technologies is strongly preferred. Solid experience in backend architecture including system design patterns, cloud infrastructure, scalability, and reliability. Proficient in cloud-native architectures using AWS (preferred). Experience with Azure or GCP is a plus. Strong foundation in software design principles, design patterns, and clean architecture. Demonstrated experience designing and implementing complex, multi-generation software products. Deep understanding of Healthcare softw...

Job Description Job Title : Post Market Surveillance (PMS) Specialist The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance. Key Responsibilities: The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including: Creation and maintenance of PMS Plans Creation and maintenance of PMS Reports Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports Preparation and update of PSURs Audit and Inspection support Own and effectively drive CAPAs on post-market surveillanc...

Job Description Job Title : Post Market Surveillance (PMS) Specialist The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance. Key Responsibilities: The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including: Creation and maintenance of PMS Plans Creation and maintenance of PMS Reports Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports Preparation and update of PSURs Audit and Inspection support Own and effectively drive CAPAs on post-market surveillanc...

About OptraSCAN: We are a fast-growing health-tech company focused on building AI-enabled digital pathology solutions that are used by hospitals, laboratories, CROs, and pharma companies in over 30 countries. Our mission is to make precision diagnostics more accessible, efficient, and intelligent. With OptraSCAN , transitioning from conventional microscopy to digital pathology becomes seamless. Our solutions enable effective acquisition of whole slide images, along with features such as viewing, storing, archiving, real-time sharing, and reporting. We offer various pricing models to suit your specific needs and budget. Job Description: OptraSCAN is seeking a highly detail-oriented and knowle...

Job Description The Software Quality Engineer is responsible for Software Quality relative to the design and development of company products, software reliability, developing and maintaining processes and procedures, and assuring adherence to the software development lifecycle across Abbott. Responsible for maintaining a strong collaborative partnership with cross-site and cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. About the team: The Software Quality Engineering team provides a fast-paced, dynamic work environment where engineers work closely with cross functional teams to provide software services to p...

Position: Manufacturing Process Engineer Reporting to: Quality Manager Location: Pillaipakkam (Factory) Summary: As a process engineer, you will analyse and optimize manufacturing and industrial processes to improve efficiency and reduce costs. This includes process designing, troubleshooting, process optimization, process analysis, process documentation, quality control, project management, process automation and quality assurance. You will also collaborate with cross-functional teams, implement process improvement initiatives and contribute to the overall success of our organization. Roles responsibilities: 1.Conduct detailed process evaluations and gap analyses to identify areas for impro...

Looking for candidates with 2–4 years of strong PMS experience in the medical device domain (preferably ortho/trauma). Must be skilled in EU MDR, PSUR, trend reports, risk assessment (ISO 14971), and complaint handling. Required Candidate profile Note: This role is exclusively for PMS professionals with hands-on experience in medical devices.

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 ...

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 form...

Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer - Medical Devices The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your role: Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design. Validate key design inputs like usability, reliability, performance, supportabili...

Designation: Staff Specialist Labeling & Technical Publications Experience: 7–11 years Location: Gurgaon (GGN) or Bangalore (BLR) Interview Rounds: 8 Work Mode: Hybrid / Onsite Role Overview We are seeking a highly skilled professional to manage and coordinate global labeling and technical publications for medical device products. This role involves regulatory documentation, translation workflows, quality compliance, and cross-functional project leadership within a regulated environment. Key Responsibilities Manage and approve labeling jobs using tools like Microsoft Teams Planner and PLM systems. Coordinate document translations with external vendors and ensure regulatory compliance. Publis...