CQ Specialist Core QMS

DePuy Synthes is recruiting for a(n) 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). This role partners closely with Quality, Regulatory Affairs, and cross-functional teams to ensure global processes meet internal standards and applicable regulatory requirements. The position plays a key role in maintaining audit readiness, strengthening process consistency, and enabling a culture of quality and compliance across DPS., * 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, andfollow-upof corrective actions.
• Track, analyze, and report QMS metrics and performance indicators to supportdata-drivendecision-making.
• Collaborate withcross-functionalstakeholders 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., Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Education

• Required: Bachelor's degree in Life Sciences, Engineering, Quality, or a related discipline
• Preferred: Advanced degree or formal training in Quality or Regulatory Affairs

Experience and Skills

Required:

• 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 Englishrequired; German preferred
• Travel: Limited; Up to 10%, primarily international
• Certifications: ASQ or equivalent Quality certification preferred, Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com (https://www.jnj.com.) . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.