To provide Quality Engineering Support to production operations and design areas, particularly in instrument manufacturing in accordance with Company procedures and regulatory requirements.
Support operations providing directed quality engineering support. Ensuring solutions are compliant, in the most efficient manner with ISO 13485 and FDA 21 CFR Part 820.
* Ensuring appropriate risk management documentation such as risk analysis, pFMEA and dFMEA are up-to-date and appropriate at all times.
* Review and approval of quality related documentation via ORACLE PLM or other systems, particularly relating to upkeep of manufacturing documentation and Device Master Record.
* Assist in the development process optimisation, measurement system analysis and formal process validation techniques.
* Leading, facilitating and participating in formal problem solving to overcome production issues.
* Where required support of computer software and automated process validation activity.
* Compilation and reporting Quality Measurement Indices as required.
* Supporting Non Conformance handling relating to production concerns.
* As CAPA team member to perform corrective and preventive action (CAPA) activities in accordance with the CAPA system.
* Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of GDP and GMP.
* Comply and work within all current H&S rules and guidelines.
* Adhere to the standards of behaviours, policies and procedures as laid out in the Employee Handbook.
HND or equivalent calibre in engineering, science or technology discipline.
KNOWLEDGE, SKILLS AND ABILITIES:
working as a quality engineer
* Experience of batch or continuous flow manufacturing environment
* Experience precision mechanical small scale components
* Experience producing high standard documentation within regulated industry
* Possibly experience packaging and sterilization processes
* Ability to apply standard quality engineering inferential statistical tools
- hypothesis testing
- capability and statistical tolerance, basic DoE
* Knowledge production, labelling and environmental requirements QSR21P820
* Knowledge of process development and process validation techniques
- Validation of automated processes
* Detailed pFMEA development
* Ability to interpret technical drawings and mechanical design specifications
* Systematic approach to problem solving
* High level of technical report writing
* Able to review others documentation and provide constructive value added collaboration
* Measurement System Analysis including destructive & attributes techniques
Job Type : Permanent
Location : Cardiff
Salary : £33k - £35k pa
Date Advertised : 17 Feb 2013
Sorry, this position is no longer available.
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