Our client is a global medical device healthcare solutions company who are committed to improving lives through medical technologies, services, and solutions. They operate across 350 facilities in 150 countries, with an innovative portfolio of over 46,000 patents. They are currently looking for an experienced Senior Quality Engineer to join their team in Galway.
Reporting to the Program Manager, key areas of responsibility will include but not be limited to:
- Work to ensure a smooth transition of product Quality responsibilities from DAE to the Post Market Product Assurance group
- Prioritise timely completion of complaint investigations, CAPA decisions, and DHR reviews
- Ensure corrective action decisions and investigations are based on sound engineering analysis and review
- Develop and maintain a robust process for identifying and monitoring root cause failure mode`s, frequency, and severity
- Provide statistical data to QA and management on product performance, effectively describing clinical observations and the relationship with device performance
- Represent QA in product Risk Analysis updates for assigned products
- Collaborate with returned product analysis lab to derive root cause and lead failure investigation activities for returned products
- Demonstrate high level engineering thought processes that are based on both driving business objectives and product quality improvements
Key experience and competencies include:
- Degree in Quality, Science or Engineering and a minimum of 2 years' experience in a similar role
- Established and productive individual contributor
- Willingness and availability to travel on company business
An excellent pay rate is on offer with this role.
To discover more about this opportunity, apply now or contact Paul Wheatley at HRM on 087 344 9559 for a confidential discussion.