Manufacturing Engineer - Medical Device

Job Title: Manufacturing Engineer - Medical Devices

Roles & Responsibilities

• Implement risk management activities as per ISO 14971.
• Ensure compliance with ISO 13485 and FDA 21 CFR 820.
• Perform PFMEA to identify and mitigate process risks.
• Execute validation activities: IQ, OQ, PQ.
• Support TMV (Test Method Validation) and define CTQ (Critical to Quality) parameters.
• Maintain QMS documentation and support audits.
• Drive CAPA, root cause analysis, and continuous improvement.