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Job Description
Quality Engineering Manager sought for a global medical device company expanding operations to Galway, with a focus on delivering best-in-practice Quality Engineering and driving performance and compliance.
Job Description
Our client, a leading medical device company, is seeking a Quality Engineering Manager to lead and develop the Quality Engineering function, ensuring compliance with Quality System requirements and driving performance and compliance.
- 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.