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Quality Engineer

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  • Posted By: Polytec Personnel
  • Address:
  • Contact:
  • Date Posted: 8th Oct 2008
  • Salary: £neg
  • Location: Cambridge
  • Reference Code: 20968
  • Views Since Posting: 116
  • Full Description:

    Our client is currently seeking a Quality Engineer to contribute to the development and continual improvement of the Quality Management System Development & Manufacturing processes and procedures and deliver training.

    MAIN DUTIES:
    *Ensure that quality product manufacture and release requirements are met, investigate and report any customer complaints.
    *Ensure that goods-in requirements are met and work with suppliers to assure their consistent performance and delivery.
    *Undertake internal and external auditing and tracking of corrective and preventive actions.
    *Schedule calibration of Quality, R&D and Operations equipment and manage the supplier approval and monitoring of calibration services.
    *Contribute to internal and external project meetings, design reviews and risk analysis.
    *Assist process development engineers in equipment specification, acceptance testing and validation.
    *Review of various quality related internally and externally issued documents.
    *Co-ordinate and support of the Company's product development, operations and marketing activities and facilities as requested from time to time.
    *Project related (or departmental budget) financial management as requested from time to time.

    SKILLS:
    *Sound understanding of Quality systems and there management
    *Thorough understanding of ISO 13485
    *Acquaintance with regulators such as FDA
    *Trained auditor
    *Six Sigma knowledge
    *Able to produce concise reports
    *Highly competent with Microsoft Excel
    *HND / Degree in an Engineering discipline
    *A minimum of four years experience in a similar role within the medical device industry
    *Experience of working within quality systems essential, e.g. ISO 13485 and ISO 9001

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