DePuy Synthes is recruiting for a CQ Specialist Core QMS, located in Zuchwil, Solothurn, Switzerland. The CQ Specialist Core QMS supports the effectiveness, compliance, and continuous improvement of the DePuy Synthes Quality Management System (QMS).
Key Responsibilities Support the maintenance, implementation, and continuous improvement of the Core Quality Management System (QMS).
Author, review, and update global quality procedures, work instructions, and related documentation.
Ensure QMS processes align with applicable regulatory requirements (e.g., ISO 13485, FDA QSR, MDR) and internal standards.
Support internal, external, and regulatory audits, including preparation, execution, and follow‑up of corrective actions.
Track, analyze, and report QMS metrics and performance indicators to support data‑driven decision‑making.
Collaborate with cross‑functional stakeholders to assess process changes and support change management activities.
Support CAPA, deviation, and continuous improvement initiatives related to QMS processes.
Contribute to training activities to ensure effective understanding and adoption of QMS requirements.
Qualifications Education: Bachelor’s degree in Life Sciences, Engineering, Quality, or a related discipline.
Preferred: Advanced degree or formal training in Quality or Regulatory Affairs.
Experience: 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.
Preferred: Experience working in a global or matrixed organization.
Familiarity with digital QMS tools and document management systems.
Knowledge of EU MDR and other international regulatory frameworks.
Experience supporting process harmonization or global quality initiatives.
Lean, Six Sigma, or continuous improvement exposure.
Strong documentation, technical writing, and organizational skills.
Effective communication skills and ability to collaborate across functions.
Other Languages: Fluency in English required; German preferred.
Travel: Limited; Up to 10%, primarily international.
Certifications: ASQ or equivalent Quality certification preferred.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected under federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, internal employees contact AskGS to be directed to your accommodation resource.
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