Our client, a global medical device company expanding their operations to Galway, is seeking to hire a Quality Engineering Manager.
This is a fully remote position with occasional travel to their Galway office.
Responsibilities:
Lead and develop the Quality Engineering function to deliver best-in-practice Quality Engineering, driving performance and compliance.
Take responsibility for compliance with Quality System requirements, including Product Release, Non-conforming Material, Supplier Management, Continuous Improvement, CAPA, and Simplification Initiatives.
Ensure that manufactured products meet the requirements of end-users, Regulatory Authorities, and the company.
Develop and maintain performance measurements and report on these during management review meetings and quality performance meetings.
Liaise with Regulatory bodies to ensure Quality Systems compliance by all departments and personnel.
Manage ongoing Quality issues and present technical data to stakeholders to ensure prompt decisions on related issues.
Requirements
A degree in Engineering, Technology, or Science.
Demonstrated audit/inspection experience.
Understanding of EN ISO 13485 and FDA regulations.
Formal Audit Training.
CQM / CQE courses preferred.
Experience Requirements
10+ years’ experience in a regulated medical device company.
Knowledge of QMS Requirements and Regulations.
Knowledge of the EU MDR, ISO 13485, and FDA QSR.
Experience in quality audits by Notified Bodies and FDA.
Relevant experience and knowledge with the Risk Management process according to ISO 14971.
Previous experience with biocompatibility testing (ISO 10993 requirements).
Previous experience and knowledge with the ETO sterilization process.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706 717