Description
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Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Zuchwil, SwitzerlandJob Description:
DePuy Synthes is recruiting for a(n) Commercial Quality Specialist, Supplier Management, located in Zuchwil, Solothurn.
Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics 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.
Job Overview
Senior Quality Systems (QS) Specialist acts as Regional SME (Subject Matter Expert) for selected processes and systems, coaches the wider EMEA CQ community and supports improvement and simplification of the Quality Management System in the EMEA region.
The role will interface with related organizations to ensure a consistent and systematic process is followed and that metrics are reported timely.
Key Responsibilities
- Responsible for the management of assigned Quality System processes e.g. Document & Record Management, Quality Agreements, Change Control, Repack Relabel, Purchasing Controls, Audit, CAPA, training etc.
- Serve as an SME (Subject Matter Expert) for the assigned Quality System processes e.g. Document & Record Management, Quality Agreements, Change Control, Audit & Inspection, Repack Relabel, Purchasing Controls, CAPA, training etc…
- Provide guidance and support and coaching on assigned processes & systems.
- Ensure adequate communication of quality compliance needs and status to all affected sites/organizations.
- Drive simplification, standardization, and continuous improvement of processes across the EMEA region.
- Ensure timely and consistent reporting of metrics and KPIs (Key Performance Indicators) associated with assigned processes.
- Provide regional audit/inspection readiness support.
- Builds strategic partnerships regionally and globally, and support implementation of solutions.
- Perform other related duties as required.
- Monitors compliance with company policies and J&J quality procedures
- Evaluate quality processes and recommend improvements to meet regulatory requirements
Qualifications
Education:
Bachelor’s degree required in Engineering, Life Sciences, Supply Chain, or a related scientific or technical discipline.
Advanced degree preferred.
Experience and Skills:
Required:
4–6 years of experience in Quality Assurance, Commercial Quality, or supplier quality management within a regulated medical device or pharmaceutical environment.
Previous experience leading supplier focused quality activities or workstreams.
Strong knowledge of quality management systems and supplier quality processes.
Experience managing supplier investigations, nonconformances, and CAPA.
- Experience with ISO certification, Notified body; Health authority inspection experience preferred.
- Detailed understanding of QM Systems and local/regional (EMEA) Medical Device regulations
- Understanding the linkages in Quality and Regulatory compliance in delivery to customer and health authority.
Ability to work cross‑functionally and influence internal and external stakeholders.
Strong analytical, organizational, and problem‑solving skills.
Preferred:
Experience supporting EU MDR‑regulated medical device products.
Experience conducting or supporting supplier audits and assessments.
Experience in orthopedic or implantable medical device products.
Familiarity with supplier performance metrics and risk‑based monitoring approaches.
Knowledge of continuous improvement or risk management methodologies.
Other:
Language: Fluent in English; German preferred.
Travel: Moderate international travel.
Certifications: Quality‑related certifications (e.g., ISO, ASQ) preferred.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Required Skills:
Preferred Skills:
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