Geplaatst in: Overig in Gelderland | Geplaatst: |
AMT Medical Research is a start-up medical device company that develops innovative technologies for Coronary Artery Bypass Surgery (CABG). Our head office is in Ede (The Netherlands), with research facilities at the Utrecht Science Park. To expand our quality team we are looking for a
Validation / Quality Engineer, full-time
Responsibilities:
As a Validation / Quality Engineer you support the Director Quality and Regulatory with an active participation in the ongoing validation projects for AMT's medical devices as basis for the forthcoming CE certification. Current validation activities include transport and shelf life studies. Based on the Master Validation Plan you implement systematically process validation as part of the ISO 13485 requirements.
Your role includes project management, communication with suppliers, executing in-house validation experiments, co-writing test protocols and reports.
You support the quality department with final product testing and other basic Quality Management System (QMS) processes, when required.
You have the opportunity to grow into the role of Quality Manager and execute tasks like internal audits, change management, complaint and CAPA handling.
Qualification and educational requirements:
Relevant Bachelor's or Master's degree, preferably in life sciences or a technical related topic.
At least 2 years of experience in project management or a QA position, preferably in a medical device or pharmaceutical company.
Knowledge of ISO 13485 or ISO 9001 quality management system standards, the European Medical Device Regulation 2017/745 (MDR), as well as relevant (product) standards/regulations, or willingness to acquire this knowledge.
Experience with writing and managing technical documentation and/or large complex documentation.
Required skills:
Proficient in spoken and written Dutch and English, proficiency in other languages is a plus.
Effective interpersonal communication skills - both written and oral.
Accurate, detail oriented and able to see the big picture.
Result driven, willing to take that extra step.
Ability to work independently and be self-motivated.
We offer:
An international work environment in a diverse team.
Salary according to education and experience.
25 paid holidays (based on full time) and a pension plan.
If you recognize yourself in above profile, send you application letter with motivation and your CV to . In case of questions, please contact us on the following number: 06-.