Quality Engineer Job In Na

Quality Engineer sought to support Quality Manager in ensuring high standards of quality assurance and process controls in a medical device manufacturing company.

**Job Description** We are seeking a Quality Engineer to join our team in Mayo. The successful candidate will work closely with the engineering staff and operations to ensure high standards of quality assurance and process controls. **Key Responsibilities** • Demonstrate commitment to quality policy through daily execution of sound quality practices and 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 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. **Requirements** • 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.