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Job Description
Quality Engineer for Medical Device Manufacturing Company
A Quality Engineer is needed to support the Quality Manager in a medical device manufacturing company in Mayo, ensuring high standards of quality assurance and process controls.**Key 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 Quality Management System (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 aspects 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, ISO13485 Quality System Standard, ISO 14971 Risk Management, and Canadian Regulation.
- 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.