Job Role Overview
This technical leadership position is responsible for the monitoring, approval and appraisal of suppliers from a quality perspective.
The job involves providing support and guidance to departments liaising with suppliers from an operations, engineering and quality control standpoint.
This includes supporting process/supplier validation, change requests, non-conforming product issues, corrective and preventive action program, risk assessment and associated quality system documentation.
The successful candidate will drive all assigned supplier quality engineering projects and ensure they are managed in a structured fashion and completed in compliance with relevant procedures.
Key Responsibilities:
* Manage and drive project activities to ensure timely completion of project milestones.
* Represent the team at key review meetings.
* Build effective relationships with other functions.
Requirements:
The ideal candidate will have a third-level qualification in science, engineering or a relevant technical discipline and knowledge of relevant ISO, EU, FDA medical device standards regulations.
They will also have proven knowledge and experience of all aspects of validation, including process validation and design validation, as well as good working knowledge of statistics and strong interpersonal skills.
Desirable Skills:
A degree in quality/validation/statistics would be a distinct advantage. Qualified lead auditor, preferably within the medical device industry, desirable. Proven problem-solving skills and high self-motivation required. Good working knowledge of Microsoft Office and willingness to travel on company business.
Location:
Cook Medical has been in Limerick since 1996 and the Ireland location is our European headquarters and houses our EMEA Support Centre. The supplier quality engineering team are responsible for the qualification, auditing, monitoring and assessment of all new and existing suppliers across this site.
Employee Benefits:
Our employee benefits include hybrid work model, company sponsored pension scheme, medical health insurance cover for you and your immediate family, and more.