Quality Assurance Engineer
- Design Assurance Quality Planning (i.e. new product development, design excellence, and design transfer).
- Actively participate in the design control process: planning, design input, design output, design review, design verification, design validation, design changes, and design history file maintenance.
- Apply appropriate risk management tools (i.e. FMEA's) throughout all projects and that the tools used are consistent with applicable regulatory standards and industry practices.
- Ability to effectively facilitate design reviews and requirements traceability activities
- Ensure the design history file is complete accurate and defensible for each product release
- Product quality planning through the use of quality control plans and product & process FMEA tools.
- Assure regulatory compliance by meeting or exceeding the requirements in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, CMDR, MDD, J-PAL and ISO 14971.
- Give an advice for release for delivery: preparing release documents, issuing Standard Compliance Certificate (compliance to external safety / legal standards)) and put these data into the Agile system
- Work with the R&D team to measure and improve the design control process.
- Establish a dashboard of metrics, reports and statistical techniques that indicates the level of product quality at any stage of development or manufacturing
- Conduct quality audits planned in the Product quality plan and in the yearly audit program.
- You have a BSc in Engineering or Physical Science with a minimum of 5 years direct related experience in medical device industry
- Knowledge and understanding of FDA, ISO, and MDD regulations and project management and organizational skills
- 21 CFR820 (Quality Systems Regulation)
- 21 CFR 806 (Reports of Corrections and Removals Regulation)
- SOR 98-282
- ISO 9001; ISO 13485 / 14969 ; ISO 14971
- EN / IEC 60601-1 (2nd and 3rd edition)
- IEC62304 or GPSV; Software Validation
- IEC 62366 (Medical devices - Application of usability engineering to medical devices
- As a person you have strong interpersonal and influencing skills as well as analytical/Statistical skills.
- Fluent in English
- You are able to work under pressure to meet regulatory & company requirements and timelines.
We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy. We’ll offer interesting benefits and a market conform salary. You’ll become member of the team of professionals who share your education, ambitions and your competencies. This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date!
Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals.
Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects for our clients in the Dutch “Brainport” Eindhoven region, mainly on projects at our clients’ Research & Development departments. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology.
Voor meer informatie neem je contact op met Peter Groeneveld via telefoonnummer +31 0653815170
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.