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QA Investigations Engineer
Merz Aesthetics · Lonay
Description du poste
About the role
The Quality Engineer – Investigations will lead CAPA and non‑conformance activities for Merz Aesthetics, ensuring product quality and regulatory compliance across our medical‑device and pharmaceutical portfolio.
Key responsibilities
- Manage and coordinate CAPA and non‑conformance processes in line with the Quality Management System.
- Lead investigations, perform root‑cause analysis, and drive timely resolution of quality events.
- Facilitate CAPA review boards and collaborate with internal and external subject‑matter experts.
- Monitor quality metrics to identify systemic issues and support continuous improvement.
- Support supplier investigations, audit activities, and corrective‑action follow‑up.
- Ensure adherence to global regulatory requirements (ISO 13485, FDA, MDD, MDR).
Required profile
- Bachelor’s degree in Engineering, Physical Science or equivalent; higher scientific education preferred.
- Minimum 5 years experience in a medical‑device or pharmaceutical environment.
- Strong knowledge of regulatory frameworks (ISO 13485, US FDA, MDD, MDR) and GMP/GDP principles.
- Fluency in written and spoken English and French.
Required skills
- Microsoft Word, Excel, PowerPoint, Visio, Access
- Adobe suite
- Quality System Management Software
- CAPA, Non‑Conformance, Root‑Cause Analysis
- Six Sigma DMAIC methodology
- Project management
- Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
What we offer
- Flexible working hours and home‑office options where applicable.
- Generous annual leave and work‑life balance initiatives.
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Merz Aesthetics
Lonay
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