CAPA Specialist / CAPA Manager

  • Location

    Utrecht, Netherlands

  • Sector:

    Manufacturing

  • Job type:

    Permanent

  • Salary:

    £50000 - £70000 per annum

  • Contact:

    Sarah Lane

  • Contact email:

    slane@meridianbs.co.uk

  • Job ref:

    896658SL_1562768026

  • Published:

    10 days ago

  • Expiry date:

    2019-08-09

  • Startdate:

    ASAP

  • Consultant:

    Sarah Lane

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.

You will focus on maintaining or implementing compliance systems within this fast growing medical device manufacturer.

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.