Salary: 30 - £34/hour Negotiable
Category: Engineering & Technical
Job Type: Contract
Job Location: Cardiff, Wales
Posted on: 03/03/2010

Senior Quality Engineer



PURPOSE/SUMMARY

Quality Engineering project team member working on new electrosurgical medical device designs, in particular working on advanced quality planning activities of a RF based device.



ESSENTIAL DUTIES AND RESPONSIBILITIES

• Act as a project member, providing quality engineering and regulatory expertise in support of the project. Ensuring solutions are compliant, in the most efficient manner with ISO 13485, FDA 21 CFR Part 820, MDD 93-42-EEC, IEC60601

• Lead and facilitate the team in review update and all risk management ensuring risk analysis are updated and ISO 14971 compliant, ensure all component and process risks are identified using dFMEAs and pFMEAs and other techniques. Ensure risk information is fed into the design process and suitably mitigated.

• Create Verification and Validation plan for the project covering both product design and manufacturing process

• Create remedial project quality plan to identify improvement actions in the design cycle

• Review and approval of project quality related documentation via ORACLE PLM system in particular approval technical drawings and specifications, design verification and validation documents plus other project related documentation

• Assist in the development of appropriate verification and validation strategies including test method validation and recommendation of statistically sound sampling schemes

• Appraisal of suitability of vendors and vendor supplied components by application of formal vendor audits and component qualification activity based on vendors substantiated objective evidence of process control and capability. Establish regular communication with vendors during project to ensure timely and appropriate delivery of components and associated documentation

• Assist the project manager in ensuring all necessary requirements of project phase reviews are identified and met.

• Compilation and reporting Quality Measurement Indices

• Provide ad hoc Quality Engineering support in other areas such as; other projects, operations problem analysis, process analysis and process and vendor improvements

• To adhere to the “Rules & Regulations” of the company as laid out in the staff handbook



EDUCATION

• Graduate or equivalent calibre in engineering, science or technology discipline

• Experience of quality review of analogue electronic designs

• Experience of software development cycle

• Minimum of three years in a quality related field

• Experience of a Medical Device design environment

• Exposure to quickly evolving environment with cross functional team working



ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES

• Ability to interpret technical drawings

• Appreciation electronic circuit schematics

• Understanding of concept to industrialisation, product design cycle

• Strong metrology skills and understanding of inspection techniques and schemes

• Sound understanding design FMEA and system risk analysis techniques

Job Reference: 107498653
Contact Details: Personnel Futures