Quality Engineer
Recruit island
- Tourmakeady, Co Mayo
- Permanent
- Full-time
- 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.
- 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.