Our client is a world leader in the production of medical visualisation and energy systems for the medical devices industry based in South Wales. The company are currently looking to recruit a contract Quality Engineer 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:
As a Quality Engineer, you will have the following duties and responsibilities:
- Support operations or as a new design project member, 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, and their associated applicable consensus standards (IEC60601 series, ISO 11607, ISO 10993).
- Take a role in ensuring approximate 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 validationfor 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.
- Where required support of CSV activity.
- Provide ad hoc Quality Engineering support in other areas such as; other projects, operations problem analysis, process analysis and process and vendor improvements.
- All other essential duties as directed.
- To adhere to the “Rules and Regulations’ of the company as laid out in the Staff Handbook.
The successful candidate for this Quality Engineer position will have the following educational qualifications:
- HND or equivalent calibre in engineering, science or technology discipline.
- Proven experience in a quality related field.
- Preferably experience of a Medical Device environment or similar regulated industry.
- Exposure to quick evolving environments with cross functional team working.
Essential Knowledge, Skills and Abilities:
- Ability to interpret technical drawings and specifications.
- Basic understanding design and manufacturing processes.
- Strong metrology skills and understanding of inspection techniques and schemes.
- Awareness of FMEA or other risk analysis techniques.
- Experience of use of ORACLE PLM, MS Ecxel,MS Word and Minitab or equivalent.
- Ability to review technical documentation and drawings in a consistent, constructive and timely manner.
- Appreciation of vendor quality system auditing skills and vendor development ability.
- Application of a wide range of inferential statistical techniques.
- Excellent report writing and presentation skills.
- Appreciation of requirements of working in a regulatory controlled environment.
For more information or to apply for this Quality Engineer job please contact Russell Oakley at CK Science on 0114 283 9956 or email firstname.lastname@example.org. Please quote reference SH20964 in all correspondence.