How you’ll Make an Impact
* Act as Quality Management Representative / PRRC for the site
* Provide strategic leadership and direction to the QA team
* Drive compliance and excellence in quality, including NC / CAPA, change control, risk management, and complaint handling management
* Collaborate closely with the site leadership team and product segment managers to deliver robust product quality improvement initiatives and enhance quality performance
* Champion compliance and foster a strong culture of quality and GMP awareness, ensuring the site consistently meets all applicable standards
* Lead and coordinate all internal and external audits, including those conducted by health authorities, notified bodies, and customers
* Spearhead or actively contribute to projects focused on harmonizing and optimizing quality processes, working in partnership with Quality Assurance colleagues to achieve organizational objectives
* Build and maintain effective collaboration with other QA leaders to continuously strengthen and evolve the quality management system
What you bring
* Advanced degree in Biology, Pharmaceutical Sciences, or a related field (BSc/MSc or equivalent)
* Deep knowledge of Quality Management Systems for in-vitro diagnostics and comprehensive understanding of national and international regulations (ISO 13485, QMSR / 21CFR820, MDSAP, IVDD/R)
* Minimum of 10 years’ experience in Quality Assurance within the medical device or healthcare industry, including hands-on experience in in-vitro diagnostics
* Demonstrated managerial expertise with at least 8 years of experience leading and developing high‑performing teams
* Recognized for leadership, interpersonal and negotiation skills, and a strategic mindset to create value from quality team activities
* Proven commitment to meeting deadlines and delivering results in a dynamic environment
* Extensive experience managing audits and regulatory inspections
* Experience in Lean or Six Sigma projects preferred; certification Lean / 6σ Green Belt would be a plus
* Solid background in quality project management
* Fluency in French; good command of German is an asset
* Excellent proficiency in English (international working environment)
What We Offer
* Competitive salary
* Company restaurant
* Annual bonus & salary review
* Hybrid working model (3 days on site and 2 days home office)
* Employee referral scheme
* Contribution to fitness subscription
* Employee assistance programme
* Training & development programs, with access to LinkedIn Learning
If you feel attracted by this unique opportunity and you would like to take on new challenges, we would like to get to know you. Please forward your complete application (application letter, CV, copies of work certificates and diplomas/degrees, etc.) to the address given in the advertisement.
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