Contract Quality Engineer (Design, Risk, FMEA, V&V)

Contract Quality Engineer (Design, Risk, FMEA, V&V)

Cardiff to 30 p/h Ltd co 12 Months

Our client specialises in the design, development, manufacture and marketing of surgical devices for use in advanced minimal access and outpatient surgical procedures. Based in purpose built premises in South Wales it is the UK centre for R&D, they now have an immediate requirement for a Contract Quality Engineer C/QE/PH09
to support implementation of Quality Engineering Activities in product design, manufacture and vendor quality assurance in accordance with Company procedures and regulatory requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Providing directed quality engineering and regulatory expertise in support of design projects. Ensuring solutions are compliant, in the most efficient manner with ISO 13485, FDA 21 CFR Part 820, MDD 93-42-EEC
* Take role in ensuring appropriate risk management tools such as risk analysis, pFMEA and dFMEA are performed adequately
* Review and approval of quality related documentation via ORACLE PLM or other systems. Including software, mechanical and electronic technology aspects
* Assist in the development of appropriate verification and validation strategies including test method validation for products, processes and components
* Generation of process validation plans, review and approval of validation documentation
* Where required liaison with vendors including auditing and co-ordination of component qualification activities

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 related field
* Preferably experience of a Medical Device environment or similar regulated industry
* Exposure to quickly evolving environment with cross functional team working