Quality Assurance Manager

Amber Implants; Den Haag; Hybrid; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Friday drinks and company events

Canteens in building with warm meals/咖

Gym access discount

Job summary

Amber Implants, based in The Hague, seeks a Quality Manager to lead and strengthen its QMS in line with ISO 13485 and MDR. You will oversee Class III device release, equipment qualification, and supplier quality, ensuring regulatory compliance and scalable, lean quality practices as the company grows.

This hands-on role partners with R&D, Operations, and Clinical teams, advancing regulatory submissions and post-market surveillance while driving continuous improvement across the organization.

Qualifications

• 3+ years of experience in a similar role managing medical device quality activities.
• Proven knowledge of Quality Management principles per ISO 13485.
• PRRC qualification or ability to obtain per EU MDR Article 15.
• Experience with ISO 14971 risk management and FDA QSR/CE marking processes.

Responsibilities

• Maintain ISO 13485:2016 and 21 CFR Part 820 compliant QMS and related documentation.
• Serve as the Person Responsible for Regulatory Compliance (PRRC) under EU MDR.
• Prepare, review, and control quality documents, work instructions, forms, and records.
• Lead CAPAs, non-conformities, deviations, complaints, and quality investigations.
• Coordinate internal audits and support supplier and Notified Body audits.
• Support regulatory activities including technical documentation and conformity assessments.
• Provide QMS training and ensure lean, scalable quality processes.

Skills

Quality mindset

Communication skills

English proficiency

Cross-functional collaboration

Education

University degree in biomedical engineering or related field

Tools

Microsoft Office

Job description

We are looking for a Quality Manager who will lead and further strengthen Amber Implants’ Quality Management System. The primary focus of this role is to maintain, monitor, and continuously improve our QMS in accordance with ISO 13485 and MDR, ensuring that quality standards are consistently met and enhanced as the company scales. In this role, you will oversee product and process quality, including release of Class III devices, qualification of equipment and processes, and ensuring that all activities comply with internal procedures and regulatory requirements. You will work closely with key suppliers, supporting activities such as DHR reviews, supplier quality agreements, and supplier audits.

You will analyze and report quality trends, manage QA-controlled documentation, and maintain training and competency records. Additionally, you will review and approve change requests, deviations, non-conformances, complaints, and other quality system activities.

You will support Regulatory Affairs by contributing to technical documentation, design control files, and conformity assessment activities. This is a hands-on role in a fast-growing MedTech company where quality leadership, ownership, and cross-functional collaboration are essential.

This full-time position (36-40 hours per week) requires a minimum on-site presence of four days per week.

Responsibilities and duties

• Maintain, update, and improve the ISO 13485:2016-compliant QMS; and 21 CFR Part 820.
• Serve as the Person Responsible for Regulatory Compliance (PRRC) as defined under Article 15 of Regulation (EU) 2017/745 (EU MDR) and ensure regulatory compliance of the company’s medical devices.
• Prepare, review, and control quality documentation, including procedures, work instructions, forms, and records.
• Lead the management of CAPAs, non-conformities, deviations, complaint handling, and quality investigations.
• Monitor key quality metrics and ensure alignment with quality objectives and internal policies.
• Plan, conduct, and document internal audits; support supplier audits and external audits with the Notified Body.
• Coordinate and lead the Management Review process and report QMS performance to executive management.
• Oversee risk management activities in accordance with ISO 14971 and ensure that appropriate risk controls are implemented and maintained.
• Train and support employees on QMS implementation, quality processes, and best practices.
• Ensure efficient, lean, and scalable quality processes appropriate for a small but fast-growing MedTech company.
• Provide quality oversight for manufacturing partners and suppliers, including review of documentation, change notifications, and quality incidents.
• Support preparation, maintenance, and updates of technical documentation for CE marking and U.S. submissions.
• Assist in design control activities and verification/validation documentation in collaboration with R&D.
• Contribute to conformity assessment processes, including dossier preparation and interactions with the Notified Body.
• Support communication with Competent Authorities and regulatory bodies as needed.
• Help ensure ongoing regulatory compliance throughout the product lifecycle, including post-market surveillance and periodic updates.
• Participate in supplier qualification and evaluation activities from a regulatory compliance perspective.
• Work closely with R&D, Operations, Supply Chain, and Clinical teams to ensure alignment between quality, product development, and regulatory requirements.
• Provide quality and regulatory input during development, manufacturing, supplier management, and post-market activities.

Represent Quality in internal and external audits, regulatory inspections, and key project meetings.

Qualifications and Abilities

• A university degree in biomedical engineering, or a related technical field.
• At least 3 years of experience in a similar role with responsibility for managing medical device quality activities, and proven knowledge of Quality Management principles in accordance with ISO 13485.
• Hands-on experience in RA/QA activities with regular application of relevant skills and tools.
• Meet the legal qualification requirements to act as Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of Regulation (EU) 2017/745 (EU MDR).
• Work experience or proven knowledge of Risk Management principles in accordance with ISO 14971.
• Experience with medical device development under FDA Quality System Regulations (21 CFR Part 820), CE marking processes, ISO 13485, ISO 14971, and other relevant standards. Experience with the EU Medical Device Regulation (MDR 2017/745) is preferred.
• Preferred knowledge of FDA QSR, ISO standards relevant to spinal implants, and related compliance frameworks.
• Strong ability to work both independently and collaboratively within cross-functional teams.
• Excellent writing, interpersonal, and communication skills.
• Proficiency with Microsoft Office applications.
• Excellent written and verbal communication skills in English.
• And last, strong quality mindset.

Why work with us

• The opportunity to directly improve patient care by contributing to high-quality, innovative Class III medical devices.
• A dynamic, diverse, and rapidly growing start-up environment with an international footprint.
• Exposure to multiple CE submissions and FDA submissions/clearances within 3–4 years, offering accelerated regulatory and quality career growth.
• An exciting work setting where new challenges and learning opportunities arise every day.
• Strong personal and professional development opportunities as part of a small, ambitious team.
• Friday afternoon drinks and fun company events.
• Access to several canteens in the building, offering warm meals and excellent coffee.
• Discounted access to the gym and other facilities within the WTC The Hague.

We directly source all candidates – any unsolicited profiles received from recruitment agencies will be treated as direct applications.

About the company

Amber Implants is a fast-growing medical technology company based in The Hague, The Netherlands, developing innovative implants for the treatment of painful spinal fractures affecting millions of patients worldwide each year.

We operate with a flat organizational structure and a young, ambitious, and rapidly expanding team located in the WTC The Hague. Our working environment is modern, collaborative, and informal—where your contributions are recognized, your ideas are heard, and your growth is supported through constructive feedback and shared achievements.