Senior Supplier Quality & Validation Engineer

Integra LifeSciences; Le Locle; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Integra LifeSciences in Switzerland seeks a Senior Supplier Quality Engineer to lead qualification, validation, and oversight of medical device suppliers. You will drive audits, approve new suppliers, maintain ASL, and ensure GMP/ISO 13485 compliance across the supply chain.

The role requires 5–8 years in supplier quality within regulated industries, ISO 13485 lead auditor preferred, and strong cross-functional collaboration. Travel internationally and fluency in French and English are expected.

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.
• Demonstrated experience in both new supplier qualification and ongoing supplier quality management.
• Strong experience with process validation, supplier validation, and component qualification activities.
• Thorough knowledge of Medical Device regulations and standards, including ISO 13485, EU MDR/MDD, and FDA 21 CFR Part 820/QMSR.
• Auditing experience is required.
• ISO 13485:2016 Lead Auditor certification strongly preferred.
• Strong knowledge of GMP requirements and risk-based quality management principles.
• Excellent communication, collaboration, organizational, and stakeholder management skills.
• Strong analytical, problem-solving, statistical analysis, and root cause investigation skills.
• Experience with process capability analysis, validation methodologies, and quality improvement tools.
• Proficiency with ERP, PLM, and Quality Management Systems.

Aufgaben

• Lead supplier qualification, validation, and approvals including IQ/OQ/PQ.
• Establish and maintain Approved Supplier List (ASL) and supplier quality agreements.
• Perform supplier audits and supplier risk assessments in line with GMP/ISO13485.
• Drive supplier quality improvements and CAPA across QA, Purchasing, and Manufacturing.
• Collaborate with Quality Control, Engineering, and Supply Chain to support supplier transfers.
• Support regulatory inspections and audits as needed.

Kenntnisse

Auditing

QA Leadership

Risk Management

Supplier Development

Regulatory Knowledge

Languages FR/EN

Cross-functional

Ausbildung

Bachelor's Degree in Engineering

Tools

ERP

PLM

QMS

Jobbeschreibung

Integra LifeSciences in Switzerland seeks a Senior Supplier Quality Engineer to lead qualification, validation, and oversight of medical device suppliers. You will drive audits, approve new suppliers, maintain ASL, and ensure GMP/ISO 13485 compliance across the supply chain.

The role requires 5–8 years in supplier quality within regulated industries, ISO 13485 lead auditor preferred, and strong cross-functional collaboration. Travel internationally and fluency in French and English are expected.