Senior Regional Supplier Quality Specialist (EMEA)

Antler; Zuchwil; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

DePuy Synthes is seeking a Senior Quality Systems Specialist to act as Regional SME for selected processes and systems, coaching the CQ community across the EMEA region. You will ensure a consistent, timely reporting of metrics and support ongoing quality improvements.

You will interaction with cross-functional teams, support supplier quality activities, and help align QM with regulatory requirements across multiple countries including Zuchwil, Paris, and Dublin.

Qualifikationen

• Bachelor’s degree in Engineering, Life Sciences, Supply Chain, or related discipline.
• 4–6 years of experience in Quality Assurance, Commercial Quality, or supplier quality in regulated medical devices or pharmaceuticals.
• Experience leading supplier-focused quality activities or workstreams.
• Strong knowledge of quality management systems and supplier quality processes.
• Experience with supplier investigations, nonconformances, and CAPA.
• Experience with ISO certification; Notified body and health authority inspection experience preferred.
• Detailed understanding of QM Systems and local/regional (EMEA) Medical Device regulations.
• Ability to work cross-functionally and influence internal and external stakeholders.
• Strong analytical, organizational, and problem-solving skills.

Aufgaben

• Manage assigned Quality System processes and serve as SME for selected areas (e.g., Document & Record Management, Quality Agreements, Change Control, Repack Relabel, Purchasing Controls, Audit, CAPA, training).
• Provide guidance and coaching on assigned processes & systems.
• Ensure communication of quality compliance needs and status to all affected sites/organizations.
• Drive simplification, standardization, and continuous improvement across the EMEA region.
• Ensure timely and consistent reporting of metrics and KPIs for assigned processes.
• Provide regional audit/inspection readiness support.
• Build strategic partnerships regionally and globally; 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.

Kenntnisse

Quality Assurance

Supplier quality

CAPA

ISO certification

Notified body

Regulatory knowledge

Cross-functional

Analytical

Problem solving

Communication

Ausbildung

Bachelor’s degree in Engineering, Life Sciences, Supply Chain, or related discipline

Advanced degree preferred

Jobbeschreibung

DePuy Synthes is seeking a Senior Quality Systems Specialist to act as Regional SME for selected processes and systems, coaching the CQ community across the EMEA region. You will ensure a consistent, timely reporting of metrics and support ongoing quality improvements.

You will interaction with cross-functional teams, support supplier quality activities, and help align QM with regulatory requirements across multiple countries including Zuchwil, Paris, and Dublin.