An industry leading manufacturer to the medical/life science industries currently require a Quality Engineer to join their team to support new product development activities to a high level.
This is an exciting opportunity to join a global business involved in innovative and sustainable technology.
Duties & Responsibilities
- Investigating and supporting other departments in the investigation of customer complaints, CAPA’s & NC’s
- Carrying out Quality Control testing on production
- Assisting the Product Development & Engineering teams, ensuring all product development & validations are carried out to the required standard.
- Facilitating FMEA & root cause analysis activities as required
- Reviewing and amending QMS documentation e.g. procedures, WI’s, Test Methods as required
- Leading and facilitating CAPA projects as required
- Coaching Team leaders on CAPA process
- Carrying out test method validation activities
- Deputising for the Quality & Regulatory Manager as required
- Using quality tools & techniques such as, root cause analysis, DoE
- Statistical analysis methodology
Skills & Experience
- A formal education in quality e.g., CQI Certificate in Quality is preferred
- GCSE Maths & English or equivalent
- Previous experience in a quality engineering role in the medical device, IVD or pharmaceutical sectors (Advantageous).
- Ability to communicate effectively across all levels of the organisation
- Competent in MS Excel, MS Powerpoint & Minitab