Quality Assurance Manager

Barrington James; Baden-Württemberg; Hybrid; EUR 50.000 - 70.000; Vollzeit

Benefits dieser Stelle

30 vacation days

Strong pension plan

Zusammenfassung

Join an innovative medical device manufacturer in southern Germany as a Recruitment Consultant in Quality Assurance. Lead QA and RA activities, ensuring compliance with ISO 13485, MDR, and FDA standards while shaping quality strategies across products. Enjoy a competitive salary, flexible work environment, and opportunities for professional growth in a vibrant team atmosphere.

Qualifikationen

• 2+ years experience in medical devices or regulated industries.
• Strong grasp of ISO 13485, MDR, 21 CFR 820.
• Fluency in German and English.

Aufgaben

• Champion compliance in Design and Manufacturing Quality Assurance.
• Manage and enhance Quality Management System (QMS).
• Act as primary contact for audits by FDA and Notified Bodies.

Kenntnisse

Communication

Analytical skills

Documentation skills

Ausbildung

Degree in Life Sciences, Medical Technology, Quality, Regulatory Affairs

Tools

TrackWise

SAP

SharePoint

Jobbeschreibung

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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:

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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