Our client is an innovative medical device company based in Utrecht, The Netherlands. The company focuses on the research and development, manufacturing and commercialisation of a ground breaking medical device and they now seek a CAPA Specialist to implement and continuously improve the CAPA process and Quality Management Systems.
You will focus on maintaining or implementing compliance systems within this fast growing medical device manufacturer.
- 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
- Confidence working in a fast paced environment
- Solution focused 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
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:
- Competitive relocation package and assistance maybe available
- Assistance for the preferential 30% tax ruling application if applicable
- 37 days holiday per year (pro rata)
Working Hours: Full time (40 hours per week) 8 hours per day to be worked anytime between 07:00 to 19:00 Monday to Friday
To apply, or to find out more information, please click on one of the "apply" buttons
Please note that due to a high level of applications, we can only respond immediately to applicants whose skills & qualifications are suitable for this position.
Meridian Business Support is acting on behalf of our Client as a Recruitment Agency.