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.

What we offer

Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• A competitive salary;

• 35.5 vacation days;

• 8% vacation allowance and 3% year-end bonus;

• Incentive Plan;

• An excellent pension scheme;

• Various training modules.

• On-site sports facilities with classes in boxing, Zumba and Pilates.

• Mental wellbeing support via Lyra Health for you and your family members.

• Access to a dedicated prayer/meditation room.

• A high-quality company restaurant with fresh and healthy options every day.

• Excellent coffee prepared by a professional barista.

• Game room with a pool table and a ping pong table.

• Mental wellbeing support via Lyra Health for you and your family members.

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address: [email protected]

Required Skills:

Combination Products, Cross-Functional Teamwork, Inspection Readiness, IS Audit, Medical Device Manufacturing, Medical Device Quality Systems, Medical Devices, Medical Device Testing, Packaging Processes, Patient Safety, Quality Assurance (QA), Quality Auditing, Quality Management Standards, Quality Metrics, Quality Risk Assessment, Quality Systems Compliance, Regulatory Compliance, Risk Management

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/31/2026

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