CQ Specialist Core QMS
Hybrid · Zuchwil, Solothurn, Switzerland
Job Summary
CQ Specialist Core QMS supports the effectiveness, compliance, and continuous improvement of the DePuy Synthes Core Quality Management System (QMS). The role partners with Quality, Regulatory Affairs, and cross-functional teams to ensure global processes meet internal standards and regulatory requirements (e.g., ISO 13485, FDA QSR, MDR). Key responsibilities include maintaining and improving the Core QMS, authoring/updating global quality procedures and work instructions, ensuring alignment with regulatory requirements, supporting audits and CAPA/deviation activities, tracking QMS metrics for data-driven decisions, collaborating cross-functionally on change management, contributing to training on QMS requirements, and supporting continuous improvement initiatives.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Quality, or a related discipline
- Approximately 3–5 years of relevant experience in Quality, Compliance, or Regulatory Affairs within a regulated industry, preferably medical devices
- Working knowledge of Quality Management Systems and global quality standards
- Experience supporting audits and inspection readiness activities
- Ability to analyze quality data and support continuous improvement initiatives
- Familiarity with digital QMS tools and document management systems
- Knowledge of EU MDR and other international regulatory frameworks
- Experience in process harmonization or global quality initiatives
- Lean, Six Sigma, or continuous improvement exposure
- Strong documentation, technical writing, and organizational skills
- Fluency in English; German preferred
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