Global QA Manager, EMEA & APAC | Life Sciences

0513 Sensitech EMEA B.V.; Sassenheim; In loco; EUR 68.000 - 135.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

International travel up to 20%

Descrizione del lavoro

Sensitech EMEA B.V. in Sassenheim, Netherlands, is seeking a Quality Assurance Manager EMEA/APAC to lead quality activities and a regional team in a regulated pharmaceuticals environment.

You will drive compliance, continuous improvement, audit readiness, and quality excellence across global networks. You will partner with Operations, Engineering, Supply Chain, and Product teams while developing a high-performing quality team and promoting a strong quality culture.

Competenze

• 5+ years of Quality Assurance, Quality Systems, or Quality Engineering in a regulated industry.
• Strong experience in the medical device industry.
• Experience with CAPA, audits, supplier quality, investigations, risk management, and change control.
• Familiarity with ISO 13485, ISO 9001, GMP, GDP and related quality regulations.

Mansioni

• 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.

Conoscenze

Quality Assurance

CAPA

Audits

Risk management

Leadership

Formazione

Bachelor/Master in Engineering/Life Sciences/Pharmacy

Strumenti

eQMS

GAMP 5

CSV

Data integrity

Descrizione del lavoro

Sensitech EMEA B.V. in Sassenheim, Netherlands, is seeking a Quality Assurance Manager EMEA/APAC to lead quality activities and a regional team in a regulated pharmaceuticals environment.

You will drive compliance, continuous improvement, audit readiness, and quality excellence across global networks. You will partner with Operations, Engineering, Supply Chain, and Product teams while developing a high-performing quality team and promoting a strong quality culture.