Quality Assurance Manager

Barrington JamesLocation Not Available

Stellenbeschreibung:

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Recruitment Consultant | Quality Assurance | UK & Europe

Job Summary:

An innovative medical device manufacturer, part of a dynamic global medtech group, is on the lookout for a driven quality expert to lead QA and RA activities at their site in Weil am Rhein, nestled in the vibrant south of Germany. This is your chance to shape compliance across the entire product lifecycle while ensuring robust systems aligned with international standards such as ISO 13485, MDR, and FDA requirements.

Key Responsibilities

Champion compliance across both Design Quality Assurance (DQA) and Manufacturing Quality Assurance (MQA) in line with ISO 13485, MDR, and FDA 21 CFR Part 820
Manage and continually enhance the Quality Management System (QMS), overseeing the creation and upkeep of SOPs, work instructions, and controlled documents
Act as a primary contact for internal and external audits, including those by the FDA, Notified Bodies, and global clients
Own CAPA processes, handle deviations, non-conformances, and change controls with a proactive mindset
Guide updates to technical documentation to ensure EU MDR and FDA compliance
Drive and support risk management (FMEA), process validations, and controls within manufacturing
Work hand-in-hand with R&D and production to maintain quality standards throughout the product lifecycle
Educate and advise teams on regulatory expectations and internal QA/QM systems
Support worldwide submissions and regulatory strategies in coordination with headquarters
Collaborate with the corporate quality team to harmonize quality approaches across all sites

What We're Looking For:

A degree in Life Sciences, Medical Technology, Quality, Regulatory Affairs, or a similar field (or an equivalent professional background)
Solid experience in medical devices or other regulated industries (ideally 2+ years)
Strong grasp of ISO 13485, MDR, 21 CFR 820, and general quality system frameworks
Hands-on experience with tools like TrackWise, SAP, SharePoint, or other QMS/ERP systems
Fluency in German and English, both written and spoken
A confident communicator with excellent documentation skills and an analytical mindset

Why Apply?

Be part of a young, energetic team at a growing international medical technology company
Take ownership in a pivotal role with high visibility and direct impact on quality and regulatory projects
Enjoy a modern, flexible work environment with hybrid options and advanced digital tools
Benefit from a competitive salary, 30 vacation days, and a strong pension plan
High degree of autonomy with the opportunity to shape quality strategies across multiple departments

Ready to take the next step in your QA/RA career and join a thriving MedTech team in southern Germany? We’d love to connect!

Apply now or reach out for more details: