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Regulatory Affair and Quality Assurance Manager

About the role

We are looking for a Quality Assurance Specialist who leads the quality management system. The main responsibilities of Quality Assurance Specialist will be monitoring, securing, and evaluating the QMS according to the ISO 13485, MDR, to ensure agreed standards of quality are achieved and improved upon. Moreover, you will also be responsible for releasing/qualifying (class III) products, equipment, processes, and employees for their purpose. You’ll partially work on Supplier Management including but not limited to Quality Assurance Agreements and Supplier Audits. Furthermore, you work on trend data resulting from processes owned by the QA department and report the outcome. You compile and maintain all quality assurance, performance proficiency, and training records for new and current employees. Lastly, you perform the QA review and approval of Change Requests, Quality Investigations (Deviations, Nonconformance in products and processes, Product Complaints), Quality System activities, and Standard Operating Procedures.

Responsibilities and activities

  • Implement and maintain the compliance of the QMS according to ISO 13485:2016 and 21 CFR PART 820
  • Represent quality assurance and quality management
  • Produce quality documentation and lean QA processes
  • Lead the Quality and Management Review.
  • Manage CAPAs, non-conformances, complaints, and other quality related activities
  • Planand executing internal and external audits.
  • Lead and trainmployees relate to the quality management system.
  • Cooperate with R&D and marketing on product development and support them with development and maintenance of the technical files according to applicable regulatory requirements.
  • Participate in Supplier Management activities, as required.
  • Supervise and coordinating internal and external stakeholders regarding complaint handling
  • Manage the Risk Management process and ensure that reasonable risk management controls are in place.
  • Advise the project from regulatory point of view. Manage compliance to all relevant regulations, rules and standards for products and taking part in the conformity assessment procedures with coordination of all concerned departments.
  • Manage conformity assessment process and registration process for products including dossier preparation, submission to Competent Authorities or Notified Body, reviews of application and implementation.
  • Accompany development projects, issuing development-accompanying and technical documentation for medical devices, revising already existing technical documentations.
  • Communicate with responsible regulatory authorities (national/international) as well as with notified bodies.
  • Report to top management (e.g., Result of audits and status of CA/PA)

You have

  • A university degree in biomechanical engineering, mechanical engineering, engineering, or related fields.
  • At least 3 year of work experience in a similar position responsible for medical device quality engineering duties.
  • Regular and quality practice of RA/QA skills and activities.
  • Work experience or proven knowledge of principles and practices of Quality Management in accordance with ISO 13485.
  • Work experience or proven knowledge of principles and practices of Risk Management in accordance with ISO 14971.
  • Experience with medical device development under FDA Quality Systems Regulations, European Union Medical Device Directive (93/42/EEC), CE Marking process, ISO 13485, ISO 14971, and other ISO standards. Medical Device Regulation 2017/745 of experience is preferred.
  • Preferred experience with FDA Quality Systems Regulations, ISO standards related to spinal implants, and security, and /or similar compliance schemes.
  • The ability to work well on a team as well as independently.
  • Excellent writing and interpersonal and public speaking communication skills.
  • Fluent with Microsoft office applications.
  • Excellent written and verbal communications skills in English.

And lastly, a strong quality mindset!

We offer

  • The opportunity to improve patient care and deliver high-quality and highly innovative 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 medical technology company located in The Hague, The Netherlands, with a focus on the development of a new implant for treatment of painful spinal fracture which affects millions of patients globally every year.

Amber Implants has a flat organization 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).

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.