Global QA Leader — Medical Devices (EMEA/APAC)

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

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.