About the company
Amber Implants is a medical technology company based in Delft, The Netherlands. Founded in 2016, Amber Implants focuses on the design and manufacturing of innovative orthopedic implants using additive manufacturing production methods. The company develops innovative spinal cage implants which will be sold in the US and Europe.
We are looking for a Quality specialist, experienced in the field of Medical Devices, to join our company and fulfill the role of Quality Manager. There is opportunity to grow into the role of QA/RA Manager.
· Assure the quality and safety of innovative medical products by implementing a full Quality Management System (QMS) suitable for medical device development at Amber Implants, starting with a light-weight framework and expanding it over time.
· Provide the Quality corner stones that are required to support regulatory submissions of our products to both Notified Bodies and the FDA.
· Implement a Quality Management System, in conformance with FDA 21CFR820 and ISO 13485:2016 Design Controls, through the integration of internal and external/medical device industry best practices.
· Measuring Key Performance Indicators. This includes defining, measuring, analyzing KPIs, used in product and process improvement.
· Review & Approval Activities. This includes design verification and validation documentation.
· Inspection & Acceptance Activities. This includes acceptance of supplier deliverables.
· Risk Manager. Lead and participate in risk management sessions.
· Training Coordinator. Coordination, administration and evaluation of training for Amber Implants personnel.
· Design Controls. Guide the product development process and associated verification and validation activities.
· Document Controls. Supporting role for document control in product development.
· A completed university degree.
· A minimum of 5 years of full-time ‘hands-on’ work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research) including at least 3 years of Quality experience e.g. working within a certified QMS such as ISO 13485 and FDA QSR.
· Fluency with (new) EU directives/regulation, guidelines and FDA regulations;
· Demonstrable experience in writing Quality Policies and Procedures and composing technical files/regulatory dossiers suitable for regulatory submissions.
· Confident, able to communicate and collaborate with all levels within the company;
· Able to assimilate, articulate and present information at a high level;
· Excellent interpersonal skills as well as strong verbal communication and report writing skills.
Are you interested and the person we are looking for?
Please send your CV and motivation letter and CV to firstname.lastname@example.org. You can also see the vacant in our LinkedIn
If you have any questions regarding this position, please contact email@example.com.