Quality Engineer Supervisor

About the role

The Quality Engineer Supervisor leads a team of Quality Engineers, providing technical direction for validation, continuous improvement, CAPA, and quality‑system activities. The role ensures risk‑based, timely, and compliant support that meets business and customer requirements.

Key responsibilities

• Supervise and mentor Quality Engineers, assign priorities, monitor deliverables and ensure timely completion of objectives.
• Lead or support validation activities (IQ, OQ, PQ, engineering studies, re‑validation) and approve related documentation.
• Own CAPA processes, from problem definition through root‑cause analysis, implementation and effectiveness verification.
• Review and approve investigations, NCMRs, deviations, complaints and ensure evidence‑based conclusions.
• Drive continuous‑improvement projects using Lean Six Sigma, DMAIC, statistical methods, Poka‑Yoke, MSA and process capability tools.
• Collaborate with Manufacturing, Engineering, Regulatory, Document Control and Corporate Quality to resolve technical issues.
• Support internal, customer and regulatory audits and develop related procedures and training materials.

Required profile

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

Required skills

• ISO 13485 and FDA QSR compliance.
• CAPA management and non‑conformance investigations.
• Validation planning and execution (IQ, OQ, PQ).
• Statistical analysis using Minitab or equivalent.
• Lean Six Sigma, DMAIC, Poka‑Yoke, Measurement System Analysis, process capability.
• Risk management and root‑cause analysis tools.