Quality Manager

Location: Gelderland Province
Hours: 32–40 hours per week
Start Date: ASAP (latest by 20 November 2025)
Duration: 6 month (temporary contract)

Our client is a global medical technology manufacturer with multiple European sites focused on medical device production and distribution. The organization is currently integrating a new branch into its European operations and aligning quality and manufacturing systems across sites.

As part of this transition, they are seeking an Interim Quality Lead to support their manufacturing facility in the Gelderland region during a key growth and integration phase.

About the Role

The Interim Quality Lead will oversee Quality Management System (QMS) activities at the manufacturing site, ensuring compliance with ISO 13485 and MDR standards. This is a hands-on leadership role that combines operational oversight with strategic quality alignment during an ongoing integration project.

The position manages one QA Assistant and collaborates closely with Plant Management, Manufacturing, Procurement, and global Quality and Regulatory Affairs teams.

This role requires a proactive, adaptable professional who can maintain compliance, support audits, and strengthen quality operations in a small, fast-paced site environment.

Key Responsibilities

• Lead and maintain the site’s QMS in accordance with ISO 13485 and EU MDR.

• Manage daily QA operations, including documentation, CAPAs, and customer complaints.

• Support Notified Body audits, internal audits, and ongoing inspection readiness.

• Drive continuous improvement initiatives and ensure quality alignment during site integration.

• Supervise and develop the QA Assistant, providing guidance and structure.

• Partner with Manufacturing and Plant Management to ensure compliance and process control.

• Collaborate cross-functionally with global functions in Quality, Regulatory, and Operations.

Experience & Skills

• Minimum 3–5 years’ experience in a Quality Assurance role within medical device manufacturing.

• Strong working knowledge of ISO 13485 and MDR implementation.

• Experience supporting Notified Body audits and quality operations in a manufacturing environment.

• Proficient in document control, risk management, complaints handling, and CAPA.

• Independent and pragmatic mindset with strong interpersonal skills.

• Dutch language preferred (for communication with operators and production teams), but not essential.

• Bachelor’s degree (HBO) in Life Sciences, Engineering, or a related technical field.

Working Model

• Predominantly on-site due to manufacturing operations (3–4 days per week).

• 1–2 days remote per week possible after onboarding.

Contract Details

• Duration: 6 Months, extension thereafter 

• Start Date: ASAP (latest by 20 November 2025)

• Interview Process:

  1. Initial interview with the European Quality Lead and current QA Manager.

  2. Second interview with Plant Management and Quality Leadership.

  3. Teams interviews possible; final decision typically made within 24 hours.