Senior Supplier Quality Engineer - Validation Leader

integralife; Freiburg; Hybrid; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Integra LifeSciences is seeking an experienced Supplier Quality professional to lead qualification, validation, and monitoring of contract manufacturers and suppliers. You will drive supplier selection, risk assessment, and audit programs to ensure compliance with ISO 13485 and regulatory standards.

The role requires deep experience in medical device manufacturing, process validation, and CAPA management, with strong collaboration across Quality, Purchasing, and Engineering teams.

Qualifikationen

• Bachelor’s Degree in Engineering, Life Sciences, Manufacturing, Quality, or a related technical discipline is required.
• 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.

Aufgaben

• Provides quality leadership for qualification, validation, monitoring, and development of contract manufacturing sites and suppliers.
• Leads supplier selection, qualification, onboarding activities, and risk assessments.
• Maintains Approved Supplier List (ASL) and ensures up-to-date records.
• Executes risk-based supplier audit programs in line with GMP, ISO 13485, and regulatory requirements.
• Monitors supplier quality performance and drives improvement initiatives.
• Provides technical quality support to Quality Control, Purchasing, Supply Chain, Engineering, and Manufacturing.
• Reviews and approves validation plans, protocols, and reports for supplier validation.
• Ensures outsourced validation activities are performed per procedures and timelines.
• Supports new product introductions, supplier transfers, and industrialization projects.
• Addresses Supplier Change Requests and regulatory impacts; manages CAPA and investigations.
• Leads root cause investigations and drives containment, corrective, and preventive actions.
• Mentors Supplier Quality Engineers and cross-functional teams.

Kenntnisse

Supplier Quality

Quality Engineering

Auditing

Root Cause Analysis

Process Validation

Risk Management

Statistical Analysis

ERP

Ausbildung

Bachelor’s degree in Engineering/Life Sciences/Manufacturing/Quality

Tools

ERP

PLM

QMS

MS Office

Jobbeschreibung

Integra LifeSciences is seeking an experienced Supplier Quality professional to lead qualification, validation, and monitoring of contract manufacturers and suppliers. You will drive supplier selection, risk assessment, and audit programs to ensure compliance with ISO 13485 and regulatory standards.

The role requires deep experience in medical device manufacturing, process validation, and CAPA management, with strong collaboration across Quality, Purchasing, and Engineering teams.