Quality Engineer Job In Na

Job Description

Quality Engineer

We are working with a medical device manufacturing company in Mayo to recruit a Quality Engineer.

Our client requires a Quality Engineer to support the facilities Quality Manager in ensuring high standards of quality assurance, process controls and meet ISO requirements.

Main duties and responsibilities:

• Demonstrate commitment to the Quality Policy 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 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.

• 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.