Quality Manager, Production

About the role

We are seeking a Quality Manager, Production to lead and maintain our Quality Management System across all manufacturing activities. You will ensure that our medical devices meet regulatory requirements and internal specifications, supporting safe and effective patient treatments.

Key responsibilities

• Establish and maintain QMS activities for receiving, manufacturing, shipping, distribution, and reverse logistics.
• Lead incoming, in‑process, and final inspections and testing to guarantee product release compliance.
• Oversee Device History Record and Batch Record completeness, accuracy, and regulatory compliance.
• Manage inspection plans, sampling strategies, and acceptance criteria (e.g., ANSI/ASQ Z1.4, Z1.9).
• Support internal, customer, and regulatory audits and inspections.
• Approve and maintain inspection procedures, test methods, and validation protocols (IQ/OQ/PQ).
• Ensure QC processes align with ISO 13485, FDA 21 CFR Part 820, MDSAP, IEC standards, and EU MDR where applicable.

Required profile

• Proven experience in quality management for medical‑device production.
• Strong knowledge of regulatory frameworks such as ISO 13485, FDA QMSR, MDSAP, and EU MDR.
• Ability to manage inspection and release activities, audit support, and documentation integrity (ALCOA+).

Required skills

• ISO 13485
• FDA 21 CFR Part 820 (QMSR)
• MDSAP
• IEC 60601
• ISO 14971
• ANSI/ASQ Z1.4
• ANSI/ASQ Z1.9
• ALCOA+ data integrity
• IQ/OQ/PQ validation
• Functional testing
• Electrical safety testing
• Software verification
• Non‑destructive testing
• Destructive testing