Quality Assurance Manager EMEA Asia Pacific

Carrier; Nijmegen; In loco; EUR 68.000 - 135.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Competitive salary and benefits

Career development opportunities

Descrizione del lavoro

Sensitech in Sassenheim, Netherlands, seeks a Quality Assurance Manager EMEA/APAC to lead quality activities across operations and support a global network. This hands-on role drives compliance, audits, CAPAs, change controls and continuous improvement in a regulated pharma/life sciences environment.

You will partner with Operations, Engineering, Supply Chain and Product teams, leading a team of quality professionals and fostering a strong quality culture.

Competenze

• Bachelor's or Master's in Engineering, Life Sciences, Biotechnology, Pharmacy, or related.
• 5+ years QA/quality systems within a regulated industry.
• Experience in the medical device industry is preferred.
• Proven CAPA, audits, supplier quality, investigations, risk management and change control.

Mansioni

• Lead 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, supplier, certification audits and regulatory inspections.
• Oversee supplier quality activities including qualification and performance monitoring.
• 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 act as the quality expert for the business.

Conoscenze

Quality leadership

Regulatory knowledge

CAPA management

Audits & inspections

Cross-functional

Formazione

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

Strumenti

eQMS

GAMP 5

CSV

Descrizione del lavoro

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