QA Engineer

Welland Medical Ltd; Crawley; On-site; GBP 30,000 - 60,000; Full time

Job description

Welland Medical brings to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Investing in the most talented people, collaborating to create world-class, ground-breaking products and services devoted to improving peoples’ lives. We are passionate about making a difference in the world. Our reputation is based on a tradition of

improvement, ethical leadership, and total commitment to quality and safety.

Welland Medical, established in 1988, is part of the CliniMed Group, and has over 240 colleagues committed to enhancing people’s lives.

Main Duties and Responsibilities

As a QA Engineer, your main responsibilities and duties will include:

1. Ensure the QMS is adhered to and that ISO standard requirements are met and maintained
2. Assist in the improvements of QMS against ISO 13485
3. Work with manufacturing teams (Operations, Engineering and Planning Departments) in driving through the focus, teamwork and support required to ensure delivery of all key manufacturing KPI’s.
4. Maintain and report on quality metrics
5. Support training to site staff on Quality System procedures as required
6. Providing QA support and approval of CAPA and Non-Conformances
7. Assist with Corrective and Preventive Actions (CAPAs) and support CAPA teams as necessary
8. Assisting the business in closing CAPA and Non-Conformances
9. Support Manufacturing to ensure quality issues are dealt with and closed out in a timely manner.
10. Manage or assist with customer complaints and complaint reporting
11. Conduct Incoming Inspection sampling and analysis of raw materials
12. Assist in post market surveillance (PMS) and post market clinical follow up (PMCF) activities
13. Calibrate Production Equipment as necessary in a timely manner and maintain the calibration database
14. Undertake Quality Audits (Internal, Supplier) against ISO 13485 / 9001
15. Responsible for logging, monitoring, and closing audit actions, Internal, and Supplier
16. Assist with new material, Equipment, CSV, and Process validation as necessary
17. Contribute to Lean Manufacturing Six Sigma Projects and communicate progress to CI Management with regards to key KPIs

For more information please contact our recruitment team.