Quality Manager Job Description
About the Role:
This is an exciting opportunity to lead quality operations and drive excellence in internal and external manufacturing. The successful candidate will oversee internal manufacturing quality, champion supplier control, audits, SCARs, and performance monitoring, manage CAPAs, NCRs, complaints, and validation processes, and inspire a team of Quality Engineers & Technicians.
Key Responsibilities:
* Lead and evolve the company's Quality Management System (QMS)
* Oversee internal manufacturing quality and external partners
* Champion supplier control, audits, SCARs, and performance monitoring
* Manage CAPAs, NCRs, complaints, and validation processes
* Take charge during regulatory audits (FDA, Notified Body)
* Inspire and guide a team of Quality Engineers & Technicians
* Provide hands-on QA support to Operations, aligning quality with business goals
Requirements:
We are looking for a degree holder in a scientific discipline with 4+ years of experience in medical devices or pharma. A solid grasp of ISO 13485 and 21 CFR 820 is required. The ideal candidate should be a collaborative leader with excellent communication and team management skills, and have proven experience in quality systems, audits, and regulatory compliance.
Benefits:
* Be part of a game-changing technology that could help millions
* Work in an agile, fast-moving startup with global ambitions
* Enjoy meaningful work, real ownership, and a collaborative culture
* Grow your career in an expanding MedTech company poised for success