Associate Director Quality Assurance MDCP

Job Description

Welcome to the team

Are you ready to make a global impact in the field of medical devices? Join our Device Quality & Regulatory (DQ&R) Organization as an Associate Director and play a pivotal role in shaping the future of medical devices and combination products worldwide. As a vital team member, you’ll collaborate closely with diverse stakeholders—including Manufacturing, External Partners, R&D, Quality Assurance, Operations, Product Development, Regulatory Affairs, Procurement, and key suppliers—to drive innovation, commercialization, and continued success across our global portfolio.

Purpose of the role

The Associate Director, Device Quality Assurance within Device Quality & Regulatory (DQ&R) is responsible for providing quality oversight of the Device Network. This specific role is responsible for providing quality support for device assembly and packaging operations at the Haarlem, Netherlands site and will be based on-site in Haarlem. Candidates will need experience with medical devices and combination products, particularly autoinjectors as well as pre-filled syringes and co-packed products. You have the ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. In this role you will routinely face competing priorities, and must manage time effectively, while keeping stakeholders and team members informed with effective communication. This individual will be expected to function as an independent contributor, supporting global and site-specific projects. This role will serve as the primary interface between R&D, DQ&R and the Haarlem site for the following aspects:

Primary responsibilities

Act as the on-site quality authority for medical device and combination product operations requiring above-site support.

Provide Device Quality and Regulatory support for design transfer and method transfers of combination products to Haarlem.

Support device assembly and packaging qualification and validation activities, such as IQ/OQ/PQ and PPQ, at Haarlem.

Lead triage and root cause investigations of deviations affecting device assembly and packaging operations.

Coordinate evaluation and implementation of process changes impacting device assembly and packaging operations.

Oversee CAPA activities for device assembly and packaging, including approval, effectiveness checks, and metric monitoring.

Build strong partnerships across site Operations, Packaging Technical Operations, Validation, Global DQ&R, and other functions to ensure seamless device quality execution.

Represent Device Quality and Regulatory in internal and external audits, and promote a culture of early issue identification, open discussion, and effective resolution with a focus on patient safety and product quality.

Your profile

Minimum of 5 years relevant experience in quality assurance in a medical device or medical device combination product manufacturing organization.

Bachelor's degree in relevant discipline.

Strong technical and innovative problem-solving skills.

Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills.

Demonstrated ability to partner and collaborate with cross-functional personnel and experience operating in a matrix organization.

Familiarity with device design verification and design control aspects.

Strong knowledge of device assembly and packaging operations.