Job Title: Quality Manager
Salary: Competitive (DOE) + Benefits
Our exciting new client, a medical device company in the Galway area, are currently looking for a Quality Manager to join their team on a permanent basis. The Quality Manager will manage key elements of the Quality System to ensure compliance to relevant standards for the business. The successful candidate will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required.
- Lead and develop the Quality System function and team to deliver a best in practice Quality System driving performance and compliance
- Take responsibility for compliance with Quality System including, Management Review Coordinator, Management Representative, Supplier Program, CAPA, Change Control, Training, Product Quality Review, Inspection Readiness & Management, Internal Audit, Complaints, as well as Continuous Improvement and Simplification Initiatives
- Ensure that products manufactured meet the requirements of end-users, Regulatory Authorities and the company
- Develop and maintain performance measurements of the quality system and report on this at management review meetings and during quality performance meetings
- You will liaise with the Quality and Compliance Group, FDA, HPRA and other Regulatory bodies to ensure Quality Systems compliance by all departments and personnel
- Manage ongoing Quality Systems Compliance issues, and present technical data to stakeholders to ensure prompt decisions on related issues
- Other work as assigned by Managing Director
- Degree in Engineering, Technology, or Science
- 10+ years' experience working in a regulated medical device company
- Minimum of 3 years people management experience
- Demonstrated audit/ inspection management experience
- Excellent verbal and written communication skills
- In-depth knowledge of GMP Requirements and Regulations
- Ability to work within a team environment to achieve agreed company goals
- Excellent understanding of EN ISO 13485:2016, MDSAP and FDA regulations
- Formal Audit Training
- Proficiency in use of desktop software applications such as MS office
- Some travel may be required with the role
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.