Senior Quality Engineer (Medical Devices)

About the role

We are seeking a Senior Quality Engineer to lead our quality team within the medical‑device sector. You will ensure compliance with regulatory standards, drive continuous improvement, and act as a technical mentor for quality engineers.

Key responsibilities

• Supervise and coordinate the Quality team, ensuring adherence to GMP, ISO 13485, FDA QSR and corporate policies.
• Identify gaps in the Quality Management System and lead corrective‑preventive actions.
• Support internal, customer, corporate and regulatory audits and inspections.
• Lead continuous‑improvement projects to reduce risk and enhance process effectiveness.
• Participate in Material Review Board meetings and manage Customer/Supplier Corrective Action Requests.
• Develop, execute and approve validation protocols (IQ, OQ, PQ, TMV) and ensure supplier qualification.
• Analyze quality KPIs, conduct root‑cause investigations, CAPA management and problem‑solving.
• Maintain risk‑management compliance with ISO 14971 and communicate with internal and external stakeholders.

Required profile

• Bachelor’s degree in Industrial, Materials, Chemical, Electromechanical Engineering or a related field.
• 5–8 years of quality experience in medical‑device or other highly regulated environments.
• Proven experience with ISO 13485, FDA 21 CFR Part 820, Part 11 and ISO 14971.
• Strong background in risk analysis, Gage R&R, Measurement System Analysis and statistical quality tools.

Required skills

• ISO 13485 Quality Management System implementation and maintenance.
• FDA QSR (21 CFR Part 820) and Part 11 compliance.
• ISO 14971 risk‑management methodology.
• Gage R&R studies and Measurement System Analysis (MSA).
• Statistical analysis tools for quality data.
• Validation protocol development (IQ, OQ, PQ, TMV).
• CAPA management and root‑cause analysis.