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Quality Assurance Officer

About the role

Amber Implants is a forward-thinking medical device start-up specializing in orthopedics and spine. We are dedicated to innovation and excellence in improving patient outcomes. We are seeking a diligent and proactive Quality Assurance 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 the maintenance and effectiveness of the QMS (and other duties and tasks as assigned by the RA/QA manager)
  • Participates in quality assurance activities (e.g. Complaints, feedback, CAPA, quality inspection, and monitoring activities, etc.)
  • Supports risk management processes. Ensures the implementation of risk management activities by participating in risk assessment.
  • Work on PMS, DHRs, and DMR
  • Responsible for preparation and tracking of monthly metrics
  • Participation in the external and internal audits
  • Travelling within the EU to support the QA/RA manager in quality control and audit of the suppliers
  • Support the Supply chain, Design, Validation, and Clinical team from the QA side
  • Support the regulatory submissions and company objectives from the QA side

You have

  • Bachelor’s or higher degree in Life Science or engineering
  • Minimum of 2 years (but no more than 5 years) of experience in a Quality assurance position is required
  • Experience while implementing ISO 13485 and FDA requirements (preferable to have a training certificate)
  • Experience in medical device manufacturing regarding Quality Management System requirements
  • Team player, being able to work in a cross-sectional team
  • Strong communication skill
  • A learning mindset and attitude
  • Attention to detail and focus on quality
  • Basic technical and GDP writing skills, and experience while working with electronic document control systems required
  • Problem-solving skills and experience while using problem-solving tools preferred
  • Fluency in English

About the company

  • The opportunity to improve patient care and deliver high-quality products
  • The opportunity to work in a diverse, energetic, and rapidly-growing start-up with an international market
  • An exciting work environment where new challenges are faced every day
  • Personal and professional growth and development opportunities
  • Friday afternoon drink, and fun company events
  • Different canteens with warm food and good coffee in the building
  • Discounted access to GYM and other facilities of the WTC building, the Hague

About the company

Amber Implants is a fast-growing clinical-stage medical device start-up operating in the orthopedics and trauma field. We have created a novel spinal implant (VCFix Spinal System) for treating traumatic vertebral fractures in a minimally invasive approach. We have completed all preclinical testing of this product and started in-human clinical trials. Amber Implants has a flat organizational structure composed of a young, ambitious, and rapidly expanding team, located
in WTC, the Hague, with a modern atmosphere and an informal culture.

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). We are flexible in our work times, but it is preferred to be at the office when working.

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.