Are you passionate about quality in medical devices and ready to ensure products meet the highest standards for safety and compliance?
Join a forward-thinking med-tech team bringing innovative surgical solutions to the global market.
You’ll take ownership of the Quality Management System and work closely with teams across the business to maintain compliance, improve processes, and ensure exceptional product quality.
Manage and continually improve the Quality Management System in line with ISO 13485, MDR, and FDA 21 CFR 820.
Oversee processes including complaints, deviations, investigations, and CAPAs, ensuring accurate documentation and timely resolution.
Maintain the Vigilance system, handling adverse event reporting to regulatory authorities.
Plan and coordinate internal and external audits, supporting inspections by regulators and certification bodies.
Lead risk management activities throughout the product lifecycle.
Collaborate with R&D, operations, regulatory affairs, and supply chain to embed quality standards into all areas of the business.
Deliver quality training and drive continuous improvement initiatives.
Monitor and present quality metrics to senior leadership.
Degree in engineering, life sciences, or a related field, or equivalent professional experience.
Proven experience in quality management within the medical device sector.
Strong knowledge of ISO 13485, MDR, and FDA 21 CFR 820.
Experience with CAPA systems, audits, and risk management.
Familiarity with validation processes and/or CAQ systems is an advantage.
Excellent analytical skills, attention to detail, and a proactive, solution-focused mindset.
Fluent in English and German.
A meaningful role where your work directly impacts patient safety and product excellence.
The opportunity to grow professionally in an innovative, globally active med-tech company.
A collaborative, agile team with a flat hierarchy and supportive culture.
Structured onboarding, ongoing training, and development opportunities.
Flexible working options and a competitive salary with additional benefits.
Ready to shape the quality standards of cutting-edge medical devices?
Apply now or reach out to Hollie Dear at Adaptive Life Science for a confidential conversation.