Sr. Quality Engineer PSUR

Sr. Quality Engineer - PSUR (Periodic Safety Update Report)

A Day in the Life

You will drive Medtronic's commitment to product safety and regulatory excellence by:

• Preparing and compiling

  product post-market data and findings into comprehensive

  Periodic Safety Update Reports (PSURs)

  in compliance with regulatory requirements.

• Independently developing

  Periodic Safety Update Plans and Reports.

• Serving as a mentor

  to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.

• Collaborating with cross-functional teams

  to gather and analyze data related to the performance and safety of medical devices.

• Partnering with regulatory affairs and medical experts

  to ensure accurate and timely submission of PSURs to regulatory authorities.

• Continuously monitoring and staying updated

  with evolving safety regulations and guidelines to ensure PSUR compliance.

• Developing templates and training

  based on quality system regulations, applicable standards, and guidance.

• Independently reviewing all deliverables

  to ensure compliance with the development process and relevant standards.

• Delivering presentations

  to the QA organization on the status and issues of assigned projects.

• Delivering training

  to departments outside of QA.

• Demonstrating the ability to effectively play multiple roles

  on a cross-functional team, including contributor, subject matter expert, leader, and facilitator.

• Participating in audits

  when appropriate.

• Collaborating with regulatory affairs teams

  for the submission of safety reports.

Required Knowledge and Experience

• B.E. or B.Tech in Mechanical/Biomedical Engineering.

• Minimum 5-8 years of quality engineering experience

  or equivalent, and

  overall 8-12 years of experience.

• Hands-on experience with EU MDR.

• Hands-on experience on Risk Management and Design Controls for Medical Devices.

• Familiarity with

  Literature review, PMCF (Post-Market Clinical Follow-up), IMDRF coding, CAPA (Corrective and Preventive Action) and NCMR (Non-Conforming Material Report).

• Familiarity with

  ISO 13485, ISO 14971, EU MDR

  , and product-specific industry standards.
• Understanding of

  post-market surveillance processes and adverse event reporting.

• Knowledge of

  risk management principles and hazard analysis

  in the context of medical devices.
• Familiarity with

  ISO 9001, 21 CFR part 820, 21 CFR part 11

  , and product-specific industry standards.
• Familiarity with

  DMAIC or DMADV (DFSS) methodologies.

• Good verbal and written communication skills

  , including plan/report development.
• Working knowledge of and auditing experience to the

  FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation.

• Previous experience working in a

  cross-functional team environment.

Nice to Haves

• ASQ CQE, CQA, CSQE and/or CRE 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. We are committed to our employees, recognizing their contributions and providing a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

Medtronic leads global healthcare technology, boldly attacking 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, leveraging talent, diverse perspectives, and guts to engineer the extraordinary.