Quality Engineer Supervisor

About the role

The Quality Engineer Supervisor leads a team of Quality Engineers, providing technical direction and ensuring compliance with regulatory and customer requirements in a medical‑device environment.

Key responsibilities

• Supervise and mentor Quality Engineers, assign priorities, monitor deliverables and support timely completion of objectives.
• Lead validation activities (IQ, OQ, PQ), write and approve validation plans, protocols and reports.
• Own CAPA processes, ensuring robust problem definition, root‑cause analysis, implementation and verification.
• Review and approve investigations, nonconformance records and quality reports, ensuring evidence‑based conclusions.
• Drive continuous‑improvement projects using Lean Six Sigma, DMAIC, statistical methods and other quality tools.
• Collaborate with Manufacturing, Engineering, Regulatory and other functions to resolve technical issues and maintain alignment.
• Support internal, customer and regulatory audits and develop related documentation and training materials.

Required profile

• Bachelor’s degree in Engineering or related technical discipline.
• Minimum five years of experience in a regulated medical‑device manufacturing environment.
• Proven experience supervising or mentoring engineers.
• Working knowledge of ISO 13485 and FDA Quality System Regulation.
• Fluent English (B2 level or higher).

Required skills

• CAPA management and nonconformance investigations.
• Root‑cause analysis, risk management and statistical analysis (Minitab or equivalent).
• Validation of processes, equipment and software (IQ, OQ, PQ).
• Lean Six Sigma, DMAIC, Poka‑Yoke, Measurement System Analysis.
• Familiarity with ISO 13485, FDA QSR and related regulatory standards.