Quality Manager

About the role

The Quality Manager leads the Quality Assurance organization, ensuring compliance with regulatory requirements, industry standards, and customer expectations. This position provides both strategic direction and hands‑on operational leadership for the Quality Management System (QMS) across the product lifecycle.

Key responsibilities

• Maintain and continuously improve the QMS, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, MDR and customer requirements.
• Lead internal and external audits, regulatory inspections, and monitor quality metrics to drive data‑based improvements.
• Oversee incoming, in‑process, final inspection and product release activities, managing non‑conforming products, investigations, deviations and CAPAs.
• Partner with Manufacturing and Engineering on process capability, NPI, process validations (IQ/OQ/PQ) and risk‑based quality controls.
• Act as primary quality representative during customer audits, regulatory inspections and support complaint investigations and field actions.
• Support supplier qualification, monitoring, corrective actions and material‑related risk assessments.
• Lead, coach and develop Quality Engineers, Supervisors, Inspectors and Technicians, fostering a Quality‑First culture.
• Drive Lean, Six Sigma and risk‑based improvement initiatives, develop KPIs and dashboards to monitor performance.

Required profile

• Bachelor’s degree in Engineering, Life Sciences or related field; Master’s preferred.
• 7‑10+ years of progressive quality experience in the medical device industry.
• 3‑5+ years of leadership experience managing quality teams.
• Proven experience supporting FDA inspections and ISO 13485 certification audits.
• Strong knowledge of manufacturing processes, process validation and risk management.

Required skills

• FDA 21 CFR Part 820 (QMSR)
• ISO 13485
• ISO 14971
• CAPA, NCMR, SCAR management
• Validation (IQ/OQ/PQ)
• Statistical Process Control (SPC) and statistical analysis
• Root cause analysis methodologies
• Internal and supplier audit expertise
• Lean and Six Sigma methodologies
• Risk management and risk‑based quality controls
• KPI development and dashboard creation