Responsibilities may include the following and other duties may be assigned: ​

• Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices.
• Drafting and authoring PSUR or CER documents.
• 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.
• 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.
• Collaborates with engineering, regulatory affairs and manufacturing functions to ensure submission of safety reports.
• Participate when appropriate in audits.

Required Knowledge and Experience:

• B E or B. Tech in Mechanical/Biomedical Engineering
• Minimum 4-8 years of quality engineering experience.
• Familiar with Literature review, PMCF,IMDRF coding, CAPA and NCMR.
• 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, Risk Management, Design Controls for Medical Devices.
• Familiar with ISO 13485, ISO 14971,21 CFR part 820, 21 CFR part 11 and 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.
• Good verbal and written communication skills including plan / report development.

   Nice to Haves 

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

• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.