Quality Assurance Lead – Great development role!

Location:

Rotterdam – Zuid-Holland, Nederland, Netherlands

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

NonStop Consulting

Job ID:

132500071

Posted On:

02 December 2025

Quality Assurance Manager

Rotterdam-The Hague region | MedTech | Full-time (36-40 hours)
On-site presence required for at least four days per week

A fast-growing MedTech organisation in the Rotterdam-The Hague region is looking for a Quality Assurance Manager to lead, maintain, and further strengthen its Quality Management System (QMS). The company develops innovative Class III medical devices and is preparing for significant regulatory milestones, including MDR certification, market entry activities, and post-market expansion in both the EU and US.

This is a hands-on, high-impact role where you will act as PRRC, lead Quality System activities, support Regulatory Affairs, and contribute directly to the organisation’s growth. You will report to the COO and work closely with R&D, Operations, Supply Chain, Clinical Affairs, and other stakeholders. You will also supervise one QA Officer.

Key Responsibilities

Maintain, update, and continuously improve the ISO 13485 and 21 CFR 820-compliant QMS.
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Serve as the Person Responsible for Regulatory Compliance (PRRC) under EU MDR.
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Prepare, review, and manage quality documentation, including procedures, work instructions, and records.
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Lead CAPA, deviation, complaint handling, non-conformity management, and general quality investigations.
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Monitor key quality metrics and ensure alignment with quality objectives and internal policies.
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Conduct internal audits and support supplier audits and external Notified Body audits.
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Lead Management Review activities and report on QMS performance to senior leadership.
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Oversee risk management activities under ISO 14971 and ensure robust risk controls.
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Train and support employees on QMS processes and quality best practices.
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Ensure efficient, lean, and scalable quality processes suitable for a fast-growing MedTech environment.
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Provide quality oversight for manufacturing partners and suppliers.
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Support preparation and maintenance of technical documentation for EU MDR and U.S. submissions.
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Assist in design control, verification/validation files, and conformity assessment processes.
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Contribute to communication with Competent Authorities and support post-market activities.
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Work cross-functionally to align product development, operations, and regulatory activities.
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Represent Quality during audits, inspections, and key internal/external meetings.

Qualifications & Competencies

A university degree in biomedical engineering or a relevant technical discipline.
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2-3+ years of experience in a similar QA/RA role within medical devices.
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Strong understanding of ISO 13485, MDR (and optionally IVDR), and risk management per ISO 14971.
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Experience with FDA Quality System Regulations (21 CFR 820) is a strong advantage.
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Meets the legal requirements to serve as PRRC.
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Hands-on approach and experience with practical QA/RA activities.
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Strong leadership mindset: able to push back, act independently, and take ownership.
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Confident communicator with excellent interpersonal and technical writing skills.
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Able to collaborate effectively across functions and interact with external stakeholders and C-suite.
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Assertive, structured, detail-oriented, and proactive in problem solving.
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Proficiency in Microsoft Office and strong command of English (written and spoken).
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A strong quality mindset and the ability to balance compliance with operational needs.

What This Role Offers

The chance to build and lead the QMS in a company entering crucial regulatory phases.
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Steep professional growth: exposure to MDR certification, FDA pathways, post-market activities, and multiple external stakeholders.
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Opportunity to shape your own role and develop into a senior QA/RA leader.
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Continuous learning: training opportunities, cross-functional collaboration, and daily new challenges.
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A modern, dynamic, and supportive scale-up environment where your input truly matters.
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A collaborative culture with direct access to decision-makers and C-suite.
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Flexibility to work one day per week from home.
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A friendly, informal atmosphere with regular team events and a pleasant workplace setting.

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