Quality Engineer
A leading medical manufacturing company in Galway is hiring a Quality Engineer to join their team.
About the Role
The 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).
Requirements:
* 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.
Qualifications & Experience:
* 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.