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QA Investigations Engineer

Merz Aesthetics · Lonay

🇬🇧 English
Microsoft Word Adobe Quality System Management Software CAPA Non-Conformance Project Management Good Manufacturing Practice Good Documentation Practice

Job description

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.

Questions fréquentes

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Published 4 months ago

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Merz Aesthetics

Lonay