Quality Engineer Supervisor

About the role

The Quality Engineer Supervisor leads a team of Quality Engineers, providing technical direction and ensuring that validation, continuous improvement, CAPA, and quality‑system activities are risk‑based, timely and compliant with business and customer requirements.

Key responsibilities

• Supervise Quality Engineers, assign priorities, monitor deliverables and provide coaching, mentoring and performance feedback.
• Lead or support validation activities (IQ, OQ, PQ, engineering studies, re‑validation) and approve related documentation.
• Own CAPA processes, ensuring robust problem definition, root‑cause analysis, action implementation and effectiveness verification.
• Review and approve investigations, NCMRs, deviations and complaints, ensuring evidence‑based conclusions and regulatory risk assessment.
• Drive continuous‑improvement projects using Lean Six Sigma, DMAIC, statistical methods and other quality tools.
• Partner with Manufacturing, Engineering, Operations, Regulatory and Corporate Quality to resolve technical issues and maintain alignment.
• Support internal, customer and regulatory audits by preparing objective evidence and responding to technical queries.

Required profile

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

Required skills

• ISO 13485 and FDA QSR knowledge
• CAPA, non‑conformance investigation and root‑cause analysis
• Risk management and validation (IQ, OQ, PQ)
• Statistical analysis using Minitab or equivalent
• Lean Six Sigma, DMAIC, Poka‑Yoke, Measurement System Analysis