Due to our client's growth we are seeking a CAPA Engineer to consult with them on their CAPA process.
Our consultant will be responsible for implementing and continuously improving the CAPA process and our client's 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.
- 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
- Fluent written and spoken English. Dutch language is not required.
- 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