My client is a Global consulting company, who unite compliance and technologies to create a competitive advantage for Biotech, Medical Devices and Pharmaceuticals companies. You will be working for their end client who are looking for a Senior Complaints CAPA Engineer to join their team.
This unique opportunity is a 6-9 month contract role with the potential of an extension. This role is onsite based in north Hampshire. On offer is a competitive rate ranging up to £79.68 per hour depending on experience.
Key responsibilities for the Senior Complaints CAPA Engineer:
- Ensure Adequate Containment, Investigation , Risk Analysis, Root Cause, Action Plans , and Effectiveness Checks are established for CAPA.
- Drive CAPA to closure in a timely manner by working with a cross functional team during all phases of CAPA.
Knowledge/Skills Requirements:
- Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, or 820, ISO 13485 or ISO 14971 or EUMDR within a medical device company
- Strong CAPA root cause, containment, risk analysis and effectiveness checks experience
- Ability to differentiate non conformance vs CAPA
- Medical device software experience and an understanding of the importance to test all cases using functional as well as user acceptance testing to confirm suitability
- Experience with process and product validation
- 6 years of CAPA complaints handling post market experience
- Global reportability experience
Please forward your CV to nicole.cooper@nextphaserecruitment.com or phone 01403 216216 where we I would be happy to tell you more about this exciting opportunity.