Quality Supervisor II – Medical Devices

About the role

The Quality Supervisor II leads daily Quality operations, ensuring regulatory compliance, product release, and continuous improvement for complex medical devices.

Key responsibilities

• Supervise and develop Quality personnel, manage resource allocation and performance evaluations.
• Coordinate Quality Control activities, oversee inspection, release of manufacturing records, and non‑conforming material handling.
• Ensure compliance with ISO 13485, GMP, and other regulatory requirements; lead investigations, CAPA, and audits.
• Monitor quality KPIs, analyze trends, and drive continuous improvement using statistical tools and SPC.

Required profile

• Bachelor’s degree in a STEM field.
• 3–5 years of engineering or manufacturing experience in the medical‑device industry.
• Minimum 2 years of supervisory experience.
• Intermediate to advanced English communication skills.

Required skills

• Knowledge of ISO 13485, GMP, GDP, and medical‑device regulations.
• Experience with non‑conformance management, CAPA, audits, and continuous‑improvement methodologies.
• Proficiency in statistical analysis, root‑cause analysis, SPC, and quality‑management software (ERP/PLM).
• Advanced Microsoft Office skills for data analysis.