Overview The primary function of this role is to provide technical leadership within the Supplier Quality Engineering department and support monitoring, approval, and appraisal of suppliers from a quality perspective.
Key Responsibilities:
* Provide technical leadership to the Supplier Quality Engineering team
* Support the monitoring, approval, and appraisal of suppliers
* Collaborate with departments liaising with suppliers on operations, engineering, and quality control matters
* Manage process/supplier validation, change requests, non-conforming product issues, corrective and preventive action programs, risk assessments, and associated quality system documentation
Reporting Structure:
Team Lead,
Departmental Focus:
Supplier Quality Engineering Drive all assigned supplier quality projects and ensure they are managed in a structured fashion and completed in compliance with relevant procedures.
Manage project activities to ensure timely completion of project milestones. Represent the team at key review meetings. Work closely with other functions, particularly operations, IT, engineering, and regulatory teams. Lead on FDA, QSR, and ISO13485 requirements, promoting best industry practice awareness and making decisions using the quality engineering manager as the final arbitrator on critical quality matters.
Qualifications:
* Third Level qualification in science, engineering, or a relevant technical discipline
* Knowledge of relevant ISO, EU, and FDA medical device standards regulations
* Proven knowledge and experience of all aspects of validation, including process validation and design validation
* Good working knowledge of statistics
* Strong interpersonal skills with effective communication at all organisational levels
Benefits:
We offer a hybrid work model, company-sponsored defined contribution pension scheme, medical health insurance cover for you and your immediate family, life assurance, income protection cover, educational assistance, performance-related bonus, extensive health and wellness program, fully equipped gym on site, 39-hour week with flexible start and finish times, paid time off to participate in volunteer activities, free parking, and subsidised restaurant facilities.
Additional Information:
This role plays a central part in holding us to the highest standards, impacting someone's life with everything we do. We have a highly skilled QE team in Limerick, made up of four subgroups: quality engineering, supplier engineering, regulatory communications, and complaint investigations.
The supplier quality engineering team is responsible for qualifying, auditing, monitoring, and assessing new and existing suppliers across our site, ranging from quality-impacting suppliers to non-quality-impacting ones.