Quality Engineer II

Location

Secunderabad | India

Job description

As a Senior Quality Engineer you will be a key member of the Medtronic Post Market Quality Engineering team 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.

A Day in the Life

Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements.

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

Must Have

Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices.

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.

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.

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

Deliver trainings to departments outside of QA.

Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.

Hands-on experience on EU MDR.

Previous experience working in a cross-functional team environment.

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

Participate when appropriate in audits.

Familiar with ISO 13485, ISO 14971 and EU MDR and product specific industry standards.

Experience in collaborating with regulatory affairs teams for submission of safety reports.

Minimum Qualification

• B E or B.Tech in Mechanical/Biomedical Engineering
• Minimum 4-7 years of quality engineering experience or equivalence and overall 4-8 years of experience

Key Technical Competencies

• Understanding of post-market surveillance processes and adverse event reporting.
• Knowledge of risk management principles and hazard analysis in the context of medical devices.
• Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Familiar 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.

Nice to Haves

• ASQ CQE, CQA, CSQE and/or CRE certification.
• ISO 9001 Internal Auditor / Lead Auditor Cerification
• ISO 13485 Internal Auditor / Lead Auditor Cerification
• Lean Six Sigma Green Belt or Black Belt

Job tags

Salary