Senior Supplier Quality & Validation Engineer

Integra-Lifesciences; Le Locle; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

Integra-Lifesciences is seeking a Senior Supplier Quality professional in Switzerland to lead qualification, validation, and onboarding of suppliers, ensuring GMP/ISO compliance and robust risk management. You will maintain ASL, drive supplier audits, and support cross‑functional teams in quality improvements.

The role requires extensive experience in medical device supplier quality, audits, and regulatory knowledge, with willingness to travel and fluency in French and English.

Qualifikationen

• Bachelor's Degree in Engineering, Life Sciences, Manufacturing, Quality, or a related technical discipline is required.
• Minimum 5–8 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or Quality Systems within a regulated industry.
• Minimum 5 years of experience in a Medical Device manufacturing environment.
• Experience with ISO 13485:2016, EU MDR/MDD, and FDA 21 CFR Part 820/QMSR; auditing experience required; Lead Auditor preferred.
• Strong knowledge of GMP, risk-based quality management, and regulatory compliance.

Aufgaben

• Lead supplier qualification, validation, and onboarding activities in line with GMP/ISO requirements.
• Develop and maintain Supplier Quality Agreements and associated quality requirements.
• Drive supplier improvement initiatives and perform root cause investigations.
• Collaborate with Quality Control, Purchasing, Supply Chain, Engineering and Manufacturing.

Kenntnisse

Quality leadership

Supplier quality management

Auditing

Problem solving

Statistical analysis

Cross-functional collaboration

Ausbildung

Bachelor's Degree in Engineering or related field

Tools

ERP

PLM

Quality Management Systems

MS Office

Jobbeschreibung

Integra-Lifesciences is seeking a Senior Supplier Quality professional in Switzerland to lead qualification, validation, and onboarding of suppliers, ensuring GMP/ISO compliance and robust risk management. You will maintain ASL, drive supplier audits, and support cross‑functional teams in quality improvements.

The role requires extensive experience in medical device supplier quality, audits, and regulatory knowledge, with willingness to travel and fluency in French and English.