JWR Employment Specialists are working with a medical device manufacturing company in Mayo to recruit a Quality Engineer.
The role which will support the facilities Quality Manager will work closely with the engineering staff and operations to ensure high standards of quality assurance, process controls and meet ISO requirements
Main duties and responsibilities: Demonstrate commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices and the maintenance of an effective quality system. Support Quality Manager in ensuring QMS is adhered to and work with Manufacturing Engineer and Production Supervisor to ensure same. Experience of Design Control, Risk Management and Post Market Surveillance aspect of ISO13485 and other related standards. Review and address Post Market Complaints and conduct monthly meetings for same. Responsible for CAPAR's and NCMR's Conduct internal Audits and external supplier audits. Lead investigation of component/material quality issues as they arise - work with supply chain, manufacturing and suppliers to resolve issues and to disposition materials. Work with Quality Manager to support audits with external regulatory agencies (Notified Body's and Competent Authorities) and customers. Write and review validation protocols and reports to support new equipment and process introductions. Review cleanroom operating parameters and conduct trend analysis of same on monthly/annual basis. Provide support for small R&D department to ensure design control aspects of ISO13485 are met. Assist/write documents such as Design Development Plans and Design Specifications to assist R&D. Participate in new product introduction to ensure quality is built into all products early in their life cycle. Proficient in using statistical analysis for analysing data and trends. Previous experience of Gamma and EO Sterilization methods and experience of conducting validation for same would be an advantage. Participate in preparation for annual Management Review. Skill, Education and Experience Degree in Quality Engineering / Engineering / Science, or equivalent qualification Minimum 5 years work related experience of which at least 3 years experience is in the medical device manufacturing industry in a similar role. Working knowledge of the Medical Device Directive (93/42/EEC), ISO13485 Quality System Standard, ISO 14971 Risk Management and Canadian Regulation (CMDR). Good communication skills both verbal and written. Previous experience at setting up and validating a Software based QMS system would be an advantage but not essential.
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