CQ Specialist Core QMS
On-site · Zuchwil, Solothurn, Switzerland
Job Summary
CQ Specialist Core QMS role located in Zuchwil, Switzerland, supporting the effectiveness, compliance, and continuous improvement of the DePuy Synthes Quality Management System (QMS). 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). Maintains audit readiness, drives process consistency, and enables a culture of quality and compliance across DPS. Responsibilities include maintaining and updating global quality procedures and work instructions, ensuring QMS processes align with regulatory requirements, supporting internal and external audits and corrective actions, tracking QMS metrics for data-driven decisions, collaborating with stakeholders on process changes, supporting CAPA/deviation/continuous improvement initiatives, and contributing to training on QMS requirements. Required: Bachelor’s degree in Life Sciences/Engineering/Quality or related discipline; 3–5 years in Quality/Regulatory within a regulated industry; knowledge of QMS and global standards; audit experience; familiarity with EU MDR; Lean/Six Sigma exposure; strong documentation and communication skills; English; German preferred.
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
- Knowledge of EU MDR and other international regulatory frameworks
- Lean, Six Sigma, or continuous improvement exposure
- Strong documentation, technical writing, and organizational skills
- Fluent in English; German preferred
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