CAPA Specialist Quality Engineer

Employment Type

Full time

Experience

Senior

Job Function

Quality/Regulatory

Due to growth we’re seeking an experienced CAPA Specialist Quality Engineer to join our innovative team in Utrecht and play an integral role in changing the face of our industry.  Working for us you will have the opportunity to make a real difference to people’s lives. We also believe our continued success depends upon the engagement and development of our employees and we strive to provide a fun, inspiring and supportive work environment.

The position

A key member of the Quality team, you will be responsible for implementing and continuously improving the CAPA process and our QMS. Key responsibilities will also include:

  • Take a leading role in building and managing  the CAPA system and associated deliverables
  • Manage product and process Corrective and Preventive Action (CAPA) investigations spanning from identifying issues (including potential) with root cause analysis through to implementing solutions, monitoring effectiveness and reporting.
  • Partner with SQE to document Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs) arising from internal investigations.
  • Present CAPA plans during audits.
  • Report on CAPA plans and progress for internal reports and management review.
  • Work together with all levels of Management to ensure CAPA action plans are feasible and that resources needed for implementation are available.
  • Perform regular analyses and corrective action effectiveness measures for the quality system and identify opportunities for improvement.

The ideal candidate to join our team should have:

  • Demonstrable CAPA and Quality engineering experience within medical devices
  • Detailed knowledge of ISO 13485, GMP and FDA QSR
  • Degree in Mechanical/ Manufacturing / Medical Engineering or role related discipline
  • Previous experience in Six Sigma and root cause analysis
  • Strong analytical and reporting skills
  • Experienced in writing technical documentation
  • Fluent written and spoken English. Dutch language is not required.
  • Confidence working in a fast paced environment
  • Solution focussed with a high level of self-motivation, drive and tenacity
  • Able to communicate effectively with good listening skills
  • Willingness to travel up to 25% of the time

It’s a bonus if you also have:

  • QAD and SharePoint knowledge

What we offer

In addition to working on a ground breaking new product, you’ll be working in a small, friendly and highly motivated team; all ideas are welcomed and great work is rewarded. We’re also offering:

  • A very competitive salary
  • Competitive relocation package and assistance
  • Assistance for the preferential 30% tax ruling application if applicable
  • 37 days’ holiday per year (pro rata)
  • Full time (40 hours per week) 8 hours per day to be worked anytime between 07:00 to 19:00 Monday to Friday
  • Contribution towards commuting costs
  • A work environment where you can develop your skills, learn from the best and be rewarded for your imagination
  • Free, on-site parking
  • Social events and team lunches
  • Creative office vibe with a picnic area, beanbags and ping pong table
  • Informal dress code, we’re all about wearing flip-flops in the summer and boots in the winter!
  • Meaningful work with the opportunity to make a difference

Even More!

Working in Utrecht you will be working in one of The Netherlands oldest cities with a beautiful medieval centre arranged around canals. Recently voted the most vibrant city in the country (with the largest University in The Netherlands) it is the fourth largest city in the country. It is situated in the centre of the country 48km south of Amsterdam (27 minutes by train) and as such is within easy travel of a number of cities and sights. Moreover, we have a word hard/ play hard approach and believe in creating a fun, exciting work environment so ping pong breaks, team lunches and outings are usual. The free coffee and snacks help too!

Apply today

To apply please use the link below or email your CV to recruitment@vicentra.com stating that you are applying for the position of CAPA Specialist Quality Engineer. For more information, please email the above address or call Sarah Lee on +31 (0) 88 3232 896.

**We will start interviewing successful candidates without delay, therefore please submit your CV as soon as possible. If we like what we see we will contact you, if we don’t contact you within 4 weeks we’ve probably proceeded with other candidates but don’t lose heart as we might reach out to you if we have a different role or project we think might be a match**

ViCentra is an equal opportunities employer and welcomes applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age. Due to the international nature of the Company applications are only accepted in English.
Agencies: Please note ViCentra is committed to sourcing candidates directly and as such we do not accept speculative CV’s from agencies. We do however work with an approved list of preferred suppliers but in line with our Preferred Supplier List we only pay agency fees where we have a signed agreement in place and a position has formally been placed with the agency by a member of the HR team. We do not pay fees where speculative and unsolicited CV’s are submitted to ViCentra or ViCentra employees. Where this is not observed ViCentra reserves the right to contact these candidates directly and initiate discussions without payment of any agency fee.