Quality Enginr II

Must Have

• Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
• 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.
• 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.
• 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.
• Experience in collaborating with regulatory affairs teams for submission of safety reports.

Minimum Qualification

• B E or B.Tech in Mechanical/Biomedical Engineering
• Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 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.

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