Connecting professionals

CAPA Validation Engineer

Yacht Group Nederland B.V.

9049536 | EINDHOVEN | Detachering | HBO | publicatiedatum 


Over de functie

The CAPA Validation Engineer is responsible for delivering objective and documented
evidence that user requirements have been achieved by the design. He/she drives the strategy,
approach and execution of the CAPA team to validate the implementations as proposed by
the CAPA team to address the root cause of the problem within scope.

 Supporting product and software validation through development, manufacturing and into
continuation providing technical support and leadership on a cross-functional team
 Define, document, and continuously improve validation tests including conducting peer
reviews and maintaining traceability to requirements
 Working closely with marketing, usability, clinical, and design engineers to drive design
inputs and then participate in validating design outputs
 Participate in reviews of user requirements, design documents, and test related artifacts
 Perform work with little to no supervision
 Participating in CAPA process like investigation and implementation Define, document,
and continuously improve validation tests including conducting peer reviews and
maintaining traceability


To succeed in this role, you should have the following skills and experience
 Minimum 5 years’ industry experience in product development environment required
with a Bachelors degree
 Experience desired in a medical device or other regulated industry
 Statistical Analysis experience if preferred
 Working with Standards like 13485, 14971, 62366 is preferred
 Excellent written and verbal communication skills required
 Proven ability to perform problem solving and troubleshooting required
 Strong attention to detail required
 Must be self-motivated and able to work in a fast paced, team-oriented environment
 Ability to work with minimal guidance to make decisions and report progress required
 Demonstrated leadership role in validation and issue ownership including ability to
provide guidance and direction to less experienced technical personnel required
 Experience with requirements management, configuration management, issue tracking
tools, etc. required
 Experience with CAPAs highly desirable
 Experience in designing and executing usability studies or human factors engineering
(e.g. task analysis, usability FMEA, expert reviews, …)
 Experience in setting up and executing protocols for formative, summative and validation


Excellent salary


Yacht is an Employer of Choice for many BSc, MSc, or PhD tech professionals who enjoy working in the famous Dutch High Tech industry. Being part of the world wide Randstad Group, we operate as a strategic workforce partner for many international companies. We help them to build a competitive and agile workforce. This extensive network of top level employers offers our Yacht employees a lot of challenging projects, dealing with cutting edge technologies. Working for Yachts means you could work for respected tech companies like: ASML, Philips Healthcare, Philips Lighting, Philips Research, TNO, FEI company, DAF, VDL ETG, Océ and many others.  So would you like to work in the top of the global High Tech, join us.


Voor meer informatie neem je contact op met Sam Janssen via telefoonnummer 06-30463769

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.