» Quality Engineer

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 their 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

Cambridge, Cambridgeshire | Salary £neg.
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