Quality Engineer
Mason Alexander View all jobs
- Galway
- Permanent
- Full-time
- Develop, implement, and maintain quality assurance procedures and methods for control of materials and finished goods for the clients’ medical devices.
- Work as a key member of the operations team and with suppliers to ensure quality standards are met and maintained.
- Develop and execute product quality control plans, documents, and procedures.
- Provides input to risk analyses and Process Failure Mode Effect Analysis’ (pFMEAs) including with suppliers.
- Implement and enhance quality principles, gather, and analyse quality data to support product/process improvement activities.
- Oversee manufacturing related quality events in line with GMP and internal procedures, including process defects, CAPA, and complaint investigations. Disposition non-conforming material and work with manufacturer and suppliers to implement corrective and preventive actions.
- Provide quality guidance as an integral member of the operations team, influencing manufacturing activities.
- Provide quality input into process validation activities.
- Monitor quality records’ compliance and maintain documentation according to Quality System requirements.
- Assist with change control and calibration activities.
- BE/BS Degree. A post-graduate qualification in Quality Assurance is preferable although not mandatory.
- At least three to five years Quality Engineering experience or related role within the medical device industry.
- Experienced working in a medical device manufacturing environment complying with Good Manufacturing Practices.
- Ability to work on own initiative with limited supervision/guidance.
- Strong team member with the ability to identify and drive implementation of innovative quality improvements.
- Ability to collaborate and work with external suppliers and project teams, consistently meeting deadlines and ensuring that all actions are being addressed appropriately.
- Demonstrate and actively promote high levels of professional quality engineering.
- Good communication skills. Must have the ability to communicate effectively at all levels of the company and with suppliers.
- Process Validation experience desirable.
- Good administrative/organizational ability with high level of attention to detail.
- Ability to liaise with suppliers, customers, and regulatory contacts in an informed professional manner.
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