As a quality manager, you will carry a leading role in setting up, maintaining and reviewing the FDA QSR/ ISO 13485 Quality Management System (eQMS) for design, development, and manufacturing of medical devices. You will oversee the processes throughout the expanding team of 6, make sure Amber Implants is ready for Notified Body audits and maintain relations with all stakeholders.
As Amber Implants aims to expand its portfolio over the next 3 years, an important part of the job is controlling the overall quality process and actively seeking ways to make it better.
- You will coordinate and execute all the necessary actions for setting up, maintaining and reviewing Amber Implant’s FDA QSR/ ISO 13485 Quality Management System and the accompanying FDA 510 (K) and CE certification path.
- You provide the expanding team with the tools necessary to document key processes and request them in such a way you feel necessary to build a high-quality QMS.
- Together with the Amber Implants directors, you set out the timeline, direction, and required steps for the Technical Documentation, validation and verification during CE & FDA certification trajectories.
- You will oversee the CE & FDA certification process for Amber Implants’ product line.
- You will work together with certification and regulation consultants to improve your own expertise and be ready for the new MDR requirements.
- As an expert, you will train the Amber Implants team with your findings and keep them updated on changes in the medical regulation field.
- Your expertise will be required on design in- and outputs and risk analyses throughout product developments.
- WO/HBO education level
- Strong analytical skills and excellent command in English, both written and spoken.
- Prior experience with FDA QSR/ ISO 13485 standard QMS & Risk analysis
- Prior experience with CE-certification and FDA regulation.
- (Preferred) Prior experience with Notified Body audits and communication.
- Eye for detail, pragmatic and result-oriented.
- Active stance, without awaiting things to come your way.
- Reliable energetic personality that delivers what is promised.
- Ability to work independently as well as part of a team. Open for feedback.
- Ability and desire to assume a leadership role.
- Ability to build long term relationships with clients and within the Amber Implants network.
- An exciting, open work environment where new challenges are faced every day.
- The opportunity to improve patient care and deliver high-quality products.
- Personal and professional growth and development opportunities.
- A market-conform salary.
To apply, please send you motivation letter together with you full CV to firstname.lastname@example.org
For more information you can always contact us.
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