Medical QA/RA

Join our medical device team as an Operations Quality Engineer! You'll be a key QA & RA representative, ensuring product quality and regulatory compliance throughout the manufacturing process, from design transfer to shipment. Drive continuous improvement, optimize processes, and champion quality on the production floor.

Responsibilities:

• Lead QA/RA activities in manufacturing, purchasing, and warehousing.
• Maintain compliance with ISO 13485 and FDA regulations.
• Review and approve operational documents (procedures, ECOs, etc.).
• Facilitate Material Review Board (MRB) meetings.
• Implement and monitor process controls (PV, EQ, pFMEA).
• Support process validation activities (IQ/OQ/PQ).
• Monitor KPIs, collect data, and report on operational performance.
• Support CAPA investigations and external audits.
• Manage supplier quality aspects (SCARs, audits).
• Liaise between R&D and Operations for smooth transitions.

Qualifications:

• Bachelor's degree in science, engineering, or a related technical field, required.
• Minimum 5 years of Operations Quality experience in the medical device industry.
• Strong knowledge of ISO 13485 and FDA regulations.
• Excellent English communication skills.
• Proven ability to coordinate, prioritize, and resolve complex problems.
• Experience with process validation, cleanroom controls, and supplier quality management.
• Knowledge of Lean Manufacturing, 6S, and SPC.
• CQE certification is a plus.