About the role
Amber Implants is a forward-thinking medical device start-up specializing in orthopaedics and spine. We are dedicated to innovation and excellence in improving patient outcomes. We are seeking a diligent and proactive Medical Device Quality Officer to join our dynamic team. In this pivotal role, you will support the Quality Manager in maintaining our Quality Management System (QMS) and ensuring compliance with ISO 13485 and FDA requirements.
Responsibilities
- Prepares, updates, and reviews QA documentation in compliance with ISO 13485 and FDA requirements
- Support the Quality Manager in maintaining and improving the effectiveness of the Quality Management System (QMS), and perform other tasks as assigned by the RA/QA Manager
- Participate in quality assurance activities, including handling complaints, customer feedback, CAPAs, quality inspections, and monitoring activities
- Support risk management processes, including participation in risk assessments and implementation of risk control measures
- Prepare Device History Records (DHRs)
- Contribute to Post-Market Surveillance (PMS) activities and maintain the Device Master Record (DMR)
- Track and report monthly quality metrics
- Participate in internal and external audits
- Travel within the EU to support the QA/RA Manager in supplier audits and quality control activities
- Provide QA support to the Supply Chain, Design, Validation, and Clinical teams
- Contribute to regulatory submissions and support company objectives from a QA perspective
Who We Need
- 2–5 years of experience in a Quality Assurance role within the medical device industry.
- Hands-on experience with ISO 13485 and FDA Quality System Regulation; a training certificate is preferred.
- Experience with Quality Management System (QMS) requirements in a medical device manufacturing environment.
- Strong sense of responsibility with the ability to meet deadlines and manage timelines.
- Self-motivated, persistent, and results-oriented.
- Excellent team player with the ability to work effectively in cross-functional teams.
- Strong communication and interpersonal skills.
- A learning mindset and proactive attitude.
- High attention to detail and strong focus on quality.
- Basic technical and Good Documentation Practice (GDP) writing skills.
- Experience with electronic document control systems.
- Strong problem-solving abilities; experience with structured problem-solving tools is a plus.
- Fluency in English (written and spoken) is required.
The vacancy is for a full-time position (36-40 hours per week). The employees are required to work from the office for this position.
What We Offer
- The opportunity to make a real impact by improving patient care and delivering high-quality medical devices
- A dynamic and fast-paced startup environment with a diverse and energetic team, focused on international growth
- A stimulating workplace where you’ll face new and meaningful challenges every day
- Ample opportunities for personal and professional development
- Regular social events, including Friday afternoon drinks and team activities
- Access to multiple on-site canteens offering warm meals and quality coffee
- Discounted membership to the gym and other facilities within the WTC building in The Hague
About the company
Amber Implants is a fast-growing, clinical-stage medical device startup specializing in orthopedics and trauma. Our flagship innovation—the VCFix Spinal System—offers a novel, minimally invasive solution for the treatment of traumatic vertebral fractures.
Having successfully completed all preclinical testing, we have now entered the in-human clinical trial phase. Based in the WTC The Hague, Amber Implants is built around a flat organizational structure and a dynamic, international team. We foster an informal, collaborative culture in a modern work environment, where ambition, innovation, and growth go hand in hand.
We are a company that recognizes your efforts, listens to your suggestions, gives you feedback to improve, and congratulates you on your achievements, making it a pleasant work environment. The vacancy is for a full-time position (36-40 hours per week). The employees are required to work from the office for this position.
To apply, please send you motivation letter together with you full CV and motivation letter to info@amberimplants.com
For more information you can always contact us.
We directly source all candidates – any unsolicited profiles received from recruitment agencies will be
treated as direct applications.