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