Quality Engineer

My market leading client based in Cardiff requires a Quality Engineer (Process Validation Support) on a contractual basis.

EDUCATION:
- HND or equivalent calibre in engineering, science or technology discipline

ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:
Work Experience
- Preferably minimum of two years in a quality, process development or process validation field
- Exposure to formal process development and problem solving environments
- Exposure to quickly evolving environment with cross functional team working

ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Ensuring process validation activities are compliant, in the most efficient manner with ISO 13485, FDA 21 CFR Part 820, MDD 93-42-EEC, and their associated applicable consensus standards (eg ISO11607, ISO10993 and ISO 11137).
- Assist in the development of appropriate business strategies for verification and validation including consideration of test method qualification
- Generation of process validation plans, review and approval of validation documentation
- Ensuring process validation effort is aligned with appropriate risk management tools such as risk analysis, pFMEA and dFMEA
- Review and approval of other quality related documentation via Oracle PLM or other systems. Including software, mechanical and electronic technology aspects
- Advise on appropriate statistical treatment and reporting of validation results including capability analysis
- Where necessary support metrology of purchased components including test method development and liaison with vendors

CPS Group (UK) Ltd is acting as an Employment Business in relation to this vacancy.