Quality Engineer Job Description
We are seeking a skilled and motivated Quality Engineer to join our dynamic team in Galway.
Key Responsibilities:
* Drive and implement process improvements to enhance predictability, reduce risks, and improve yields.
* Provide responsive QA support to Operations to achieve quality, cost, and output objectives.
* Ensure comprehensive definition of process variables and effective management of failure modes using DOE studies and FMEA.
* Champion plant-wide quality system improvements aligned with ISO 9001 and ISO 13485 standards.
* Ensure regulatory compliance with GMP requirements from agencies such as NSAI, FDA, and TUV.
* Employ statistical techniques (e.g., SPC, CpK analysis) to monitor and improve process performance.
* Oversee change management through the ECO process and validate processes/products via Master Validation Plans.
* Lead initiatives for the implementation of quality software systems like QPulse.
* Manage Corrective Actions, MRB reviews, and internal quality audits.
* Support Lean Manufacturing initiatives and facilitate seamless product/process transfers.
* Collaborate with Quality Inspectors, Technicians, and other departments on quality initiatives.
* Address supplier performance issues, SCARs, and maintain approved vendor files.
* Engage with customers and suppliers, attending meetings and driving continuous quality improvements.
Qualifications & Skills Required:
* Approximately 4-5+years of experience in a manufacturing/med-tech environment.
* Level 7/8 qualification in Engineering or Quality related disciplines.
* Strong understanding of Quality Engineering tools and methodologies.
* Hands-on experience with Lean Manufacturing techniques.
* Familiarity with ISO 9001 and ISO 13485 standards; knowledge of EUMDR is advantageous.
* Excellent communication, organisational, and problem-solving skills.
* Ability to work effectively both independently and as part of a team.