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Quality Engineer
1 month ago
A leading medical manufacturing company in Galway is hiring a Quality Engineer to join their team.
About the RoleThe Quality Engineer will be a key member of the Quality Assurance Team, reporting to the Quality Manager. They will be responsible for maintaining high-quality standards and driving quality engineering activities in validation, manufacturing quality, and risk management activities.
Key Responsibilities:- Report any Health and Safety incidents and/or near misses.
- Electrical/Mechanical/Hydraulic/Pneumatic Isolation of equipment to ensure equipment is safe to work on.
- Ensure QMS compliance with customer requirements, ISO, and all other applicable regulatory requirements.
- Provide technical direction/input to qualification and validation activities in conjunction with the NPI, Design, Engineering, and production teams.
- Responsible for and lead validation activities (IQ, OQ, PQ, PPAP, FAI).
- Responsible for designing methods and procedures for inspecting and testing finished products.
- Review, update, and maintain existing quality management processes and procedures.
- Using quality engineering expertise to perform root cause analysis of quality issues and managing quality-related NCs and CAPAs.
- Responsible for reviewing, implementing, and maintaining quality assurance protocols and methods for processing materials into partially or finished products.
- Use data to analyse reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Participate in continuous improvement programs to enhance manufacturing, quality, and safety processes.
- Perform risk management activities (e.g., FMEA, risk assessments).
- Excellent MS Excel skills and proficiency in Microsoft Office.
- Strong attention to detail and strong verbal and written communication skills.
- Understanding/Awareness of Customer requirements in terms of quality and delivery.
- Ability to impart knowledge in a clear concise manner.
- Demonstrate working as part of a team with common goals.
- Decision-making and Reporting skills.
- Bachelor's degree or diploma in a related field (e.g., Quality Assurance, Engineering, or Life Sciences).
- 2+ years experience in quality or related discipline preferred.
