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Quality Assurance Manager EMEA Asia Pacific
Carrier
NLD2856: Warmonderweg 11 · nl
1d ago
94%
Strong
Job description
What will you be doing? As Quality Assurance Manager EMEA Asia Pacific you will lead quality activities for Sensitech's operations in Sassenheim while supporting a global quality network across EMEA and APAC. This is a hands-on leadership role where you will drive compliance, continuous improvement, audit readiness, and quality excellence within a regulated pharmaceuticals/life sciences/medical device environment. You will act as a trusted quality partner across Operations, Engineering, Supply Chain, and Product teams while leading and developing a team of quality professionals. Key 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. Do you have? · A Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, or a related discipline. · 5+ years of Quality Assurance, Quality Systems, or Quality Engineering experience within a regulated industry. · Strong experience within the medical device industry . · Proven experience with CAPA, audits, supplier quality, investigations, risk management, and change control. · Working knowledge of ISO 13485, ISO 9001, GMP, GDP, and relevant quality regulations. · Experience leading teams and influencing stakeholders across multiple functions. A hands-on approach, strong communication skills, and the confidence to drive change in a fast-paced environment. Preferred · Experience within an ISO 13485-certified environment. · Knowledge of eQMS systems, GAMP 5, CSV, and data integrity requirements. · Experience supporting pharmaceutical, medical device, or life sciences customers. What We Offer · An opportunity to shape and lead quality initiatives within a growing global organisation. · Leadership responsibility for an international quality team. · Exposure to global customers, suppliers, and regulatory requirements. · Career development opportunities within Sensitech and Carrier. · Competitive salary, benefits package, and annual bonus. · International collaboration and travel opportunities (up to 20%). Location: Sassenheim, Netherlands (primarily on-site) Travel: Up to 20% international travel Reporting to: Head of Quality / Global Pay Range: €67,500.00 - €134,500.00