Quality Engineer – Medical Device Manufacturing

About the role

The Quality Engineer ensures product quality, regulatory compliance, and continuous improvement within a fast‑paced medical device manufacturing environment. This role works closely with Engineering, Manufacturing, Operations, and Regulatory Affairs to protect patient safety and drive operational excellence.

Key responsibilities

• Maintain and improve the Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485 and related regulations.
• Lead CAPA, NCR and root‑cause investigations and implement corrective actions.
• Support validation activities including IQ, OQ, PQ, test‑method and software validation.
• Develop and execute Gage R&R studies and inspection methodologies.
• Perform risk‑management tasks such as FMEA and hazard analyses.
• Assist with internal, customer, supplier and regulatory audits.
• Collaborate with cross‑functional teams to meet quality requirements throughout the product lifecycle.
• Monitor quality metrics and drive continuous‑improvement projects using Lean Manufacturing and Six Sigma.
• Support supplier quality activities, including audits, evaluations and incoming inspection.
• Participate in design reviews and maintain design‑control documentation (DHR, DMR, DHF).
• Implement and maintain electronic Quality Management Systems (eQMS).
• Contribute to regulatory submissions, complaint investigations and post‑market quality activities.
• Develop and deliver quality‑related training as needed.

Required profile

• Bachelor’s degree in Engineering, Life Sciences or a related technical discipline.
• 3–5 years of Quality Engineering experience in a regulated manufacturing environment.
• Working knowledge of FDA 21 CFR Part 820 and/or ISO 13485 requirements.
• Experience with CAPA, NCR, root‑cause analysis, risk management and validation activities.
• Strong analytical, problem‑solving, organizational and communication skills.
• Proficiency in technical writing and documentation.
• Proficiency with Microsoft Office applications.

Required skills

• FDA 21 CFR Part 820
• ISO 13485
• CAPA and NCR processes
• Root‑cause analysis
• Risk management (FMEA, ISO 14971)
• Validation (IQ, OQ, PQ, test‑method, software)
• Gage R&R
• Lean Manufacturing
• Six Sigma
• Electronic Quality Management Systems (eQMS)
• Microsoft Office