Global QA Leader, Medical Devices (EMEA/APAC)

Carrier; Sassenheim; Hybrid; EUR 68,000 - 135,000; Full time

Job summary

Carrier's Sensitech unit in Sassenheim is seeking a Quality Assurance Manager for EMEA and APAC to lead the QMS, drive CAPA, audits and supplier quality, and mentor a global team in a regulated environment.

You will partner with Operations, Engineering and Supply Chain, maintaining ISO 13485 and GMP compliance while driving continuous improvement and ensuring audit readiness across multiple sites.

Qualifications

• 5+ years in Quality Assurance within a regulated industry.
• Strong experience with CAPA, audits, investigations and change control.

Responsibilities

• Lead and maintain the Quality Management System in line with ISO 13485, ISO 9001, GMP, and regulatory requirements.
• Drive investigations, CAPAs, change controls, non-conformance management, and complaint handling.
• Support customer audits, supplier audits, certification audits, and regulatory inspections.
• Oversee supplier quality activities, including qualification, performance monitoring, and improvement initiatives.
• Lead quality risk assessments and continuous improvement projects.
• Develop and report quality metrics, trends, and compliance performance to leadership.
• Coach and develop quality professionals across multiple locations.
• Build a strong quality culture and serve as the key quality expert for the business.

Skills

Quality Assurance

ISO 13485

CAPA

Audits

Regulatory compliance

Leadership

Quality systems

Education

Bachelor's or Master's in Engineering/Life Sciences/Pharmacy

Tools

eQMS systems

GAMP 5

CSV

Job description

Carrier's Sensitech unit in Sassenheim is seeking a Quality Assurance Manager for EMEA and APAC to lead the QMS, drive CAPA, audits and supplier quality, and mentor a global team in a regulated environment.

You will partner with Operations, Engineering and Supply Chain, maintaining ISO 13485 and GMP compliance while driving continuous improvement and ensuring audit readiness across multiple sites.