Role DescriptionDue 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.
ResponsibilitiesA 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.
RequirementsDemonstrable 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
Other informationn 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
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.