CAPA Specialist / CAPA Manager

Posted 3 months ago by Meridian Business Support
Location Utrecht, Netherlands Job Type
Salary Up to £45000 per annum Sector Manufacturing/Production

The Company:

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.

Job Responsibilities:

  • 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.

Preferred Skills:

  • 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

Personal Attributes:

  • 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

Associated Benefits:

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.

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Meridian Business Support


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