CQ Specialist Supplier management

7111-Synthes GmbH Legal Entity; Zuchwil; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Johnson & Johnson's DePuy Synthes is recruiting a Commercial Quality Specialist, Supplier Management to oversee Quality System processes, supplier investigations, CAPA, and change control across the EMEA region and beyond.

You will provide guidance, drive standardization, and ensure timely reporting of metrics while maintaining regulatory readiness with ISO, Notified Bodies, and health authority inspections.

Qualifikationen

• 4–6 years of experience in Quality Assurance, Commercial Quality, or supplier quality management within a regulated medical device or pharmaceutical environment.
• Experience leading supplier-focused quality activities or workstreams.
• Experience with ISO certification, Notified Body; Health authority inspection experience preferred.
• Detailed understanding of QM Systems and local/regional (EMEA) Medical Device regulations.

Aufgaben

• Manage assigned Quality System processes and serve as SME (Subject Matter Expert) e.g. Document & Record Management, Quality Agreements, Change Control, Repack Relabel, Purchasing Controls, Audit, CAPA, training etc.
• Provide guidance 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 associated with assigned processes.
• Provide regional audit/inspection readiness support.
• Builds strategic partnerships regionally and globally, and support implementation of solutions.

Kenntnisse

Audit Management

Quality Analysis

Stakeholder Influence

Cross-functional Collaboration

Problem Solving

Ausbildung

Advanced degree

Tools

Quality Management Systems (QMS)

Jobbeschreibung

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional

All Job Posting Locations: Dublin, Ireland, Paris, Île-de-France, France, Zuchwil, Switzerland

Job Description

DePuy Synthes is recruiting for a(n) Commercial Quality Specialist, Supplier Management

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Zuchwil, Switzerland - Requisition Number: R-098078, Paris, France and Dublin, Ireland - Requisition Number: R-099809. Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Key Responsibilities

• Responsible for the management of assigned Quality System processes and serve as SME (Subject Matter Expert) e.g. Document & Record Management, Quality Agreements, Change Control, Repack Relabel, Purchasing Controls, Audit, 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.
• Monitor compliance with company policies and quality procedures.
• Evaluate quality processes and recommend improvements to meet regulatory requirements.

Required:

• Advanced degree preferred.
• 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; Travel: Limited travel as required.
• Certifications: Quality‑related certifications (e.g., ISO, ASQ) preferred.

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.

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 by 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required 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

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