Quality Manager

About the role

The Quality Manager will lead quality control activities on the manufacturing floor, ensuring that all production processes comply with medical device, pharmaceutical, and combination‑product regulations. This position acts as the primary QA representative, providing real‑time oversight and decision‑making to safeguard product quality and patient safety.

Key responsibilities

• Maintain a strong QA presence on the shop floor and ensure adherence to approved procedures, batch records, and regulatory standards.
• Support real‑time quality decisions, including line clearances, deviation identification, and issue resolution.
• Serve as the main point of contact for shop‑floor quality concerns that could affect compliance or patient safety.
• Oversee batch record review, disposition, and product release, ensuring documentation is complete and compliant.
• Make independent, risk‑based batch release decisions aligned with site procedures and regulatory expectations.
• Lead nonconformance, deviation, and quality event investigations, ensuring timely closure.
• Drive root‑cause analysis and implement effective corrective and preventive actions (CAPA).

Required profile

• Experience in quality assurance activities within a regulated manufacturing environment.
• Knowledge of batch review, release processes, and nonconformance management.
• Ability to make risk‑based decisions and balance supply continuity with compliance requirements.

Required skills