We are supporting an innovative company in the medical device sector that is looking for a Quality Manager to lead and manage their Quality Management System (QMS) and ensure compliance with global regulatory standards. This is a key role for someone with passion for process improvement and regulatory excellence.
Key Responsibilities:
Oversee the implementation and management of the Quality Management System (QMS), ensuring compliance with ISO 13485, EU MDR, FDA (21 CFR 820), and other global regulations.
Develop and track Quality KPIs, drive process improvements, and implement corrective and preventive actions (CAPAs).
Lead internal and external audits, acting as the main interface with the Notified Body and regulatory agencies.
Ensure compliance with product introductions, changes, and lifecycle management in alignment with regulatory requirements.
Manage and support validation processes, equipment calibration, contamination control, and ensure execution of all inspection activities.
Lead and mentor the Quality team, including hiring, training, and performance management.
Oversee customer complaint investigations and drive continuous quality improvements.
Conduct Management Reviews and ensure quality-related documentation, including SOPs, test plans, and protocols, is up to standard.
Requirements:
Minimum 3 years of experience in medical devices or a similarly highly regulated industry, with knowledge of ISO 13485, cGMP, validation requirements, and regulatory compliance (EU MDR, FDA, Health Canada, UKCA, etc.) being a strong advantage.
Experience in process improvement methods and implementing CAPAs.
Previous supervisory or leadership experience preferred.
Ability to interpret and apply regulations, standards, and quality procedures.
Strong documentation and computer skills
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.
Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:
Expert advice on your CV and cover letter
Guidance on salary expectations
Personalized interview preparation
Connections to exclusive job opportunities
Assistance in negotiating the best possible offers
50% of the CVs we send to clients are accepted
Accepted or declined, either way we will provide you with feedback
We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
