7 Iso14971 Jobs

Responsibilities: Develop & implement quality systems using ISO13485, Six Sigma Green Belt, ISO9001. Conduct audits, manage CAPAs, ensure FDA/QSR/MDR compliance. Work closely with R&D for (NPI) to ensure quality planning (DFMEA, PFMEA, Control Plan)

Job Description Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But itu2019s not just what we do, itu2019s who we are. We are 80,000, wonderfully unique individuals, with two things in common. and a relentless determination to deliver on our customersu2019 needs. Itu2019s what inspires us to create meaningful solutions u2013 the kind that make a real difference u2013 when it matters most. The world and our customersu2019 needs are changing faster than ever before and while we are proud of what we do already, we know w...

Project Manager for medical device development Phillips-Medisize, a Molex company, is looking for an experienced Project Manager for Global Innovation Development in Bangalore, India. If you are interested in being part of a project organization and passionate about creating unique products for people who need medical treatment it might be you, we are looking for. About The Position You will be leading cross functional development projects, delivering new medical devices to our global pharma customers with focus on customer requirements and business value. As a Project Manager you are part of scoping the projects in the contractual agreements and you establish and align deliveries with the c...

As a Staff Electrical Engineer at Olympus Corporation, you will play a crucial role in the technical execution of electrical engineering projects within the company. Reporting to the Associate Director, you will be responsible for providing technical leadership while also overseeing certain project management aspects. Your collaboration with Global R&D and India leads will be instrumental in driving the design, development, and troubleshooting of electrical systems for medical devices. Your primary responsibilities will include leading the hands-on development and execution of electrical designs, ensuring high performance, reliability, and regulatory compliance throughout the project lifecyc...

Led design & development/sustenance of Class II/III medical devices (electromechanical, disposable, implantable). Managed Design History Files (DHF) and ensured compliance with ISO 13485 , IEC 60601 , FDA & EU MDR . Led risk management (ISO 14971) activities including FMEA (Design & Process) and hazard analysis. Developed design inputs/outputs, V&V plans , test protocols, and technical reports. Collaborated with cross-functional teams (QA, RA, Manufacturing, Supply Chain, Clinical) for design transfer . Conducted design reviews to ensure safety, reliability, and manufacturability. Executed test method & process validations ; supported FEA coordination for design analysis. Contributed to regu...

You will be responsible for embedded hardware design with a focus on digital circuits. Your key responsibilities will include: - Developing new hardware solutions from initial requirements through prototypes to production-ready. - Designing embedded circuits, including component selection, Spice simulation, control loop design, power supplies, signal integrity check, interface designs, protocol analysis, mechanical interference, thermal analysis, high-reliability, long availability, BOM management, etc. - Coordinating with Layout engineers for proper layout design inclusive of power supplies routing, signal integrity, thermal dissipation, clear documentation, etc. - Maintaining existing desi...

Job Description Job title: Quality Engineer, Products and Systems Your role: Be part of Project team and participate in defining product design input, requirements, V&V, output and design transfer requirements and plans. Ensure product quality, compliance and state of art throughout the product lifecycle. Reaffirm that design input are transferred to product design and verified to confirm that design output meet the design input. In collaboration with multi-disciplinary team, lead the design for reliability to create a reliability plan and include the reliability requirements in product design. Ensure that reliability requirements are met through test, verification and validations, as applic...