Quality Systems Manager
Global Medical Device with a huge presence in Galway is seeking an experienced quality system professional to join their business as a Quality Systems Manager.
Reporting to the Quality Director the Quality Systems Manager will be the responsibility for maintaining and driving continuous improvement of the Plants Quality System.
The Quality Systems Manager is responsible for the administration, supervision, and development of the Galway Quality Systems functions.
Job Responsibilities (full job spec available upon request)
- Ensuring that the quality system requirements are effectively established and effectively maintained in accordance with specific regulations
- Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications.
- Develop, track, and report on t administrative systems
- Support regulatory agency and customer quality audits. Act on behalf of Plant Management during audits
- Ensure all aspects of the site QMS are managed and developed in line with regulatory standards, and ensure a culture of continuous improvement is in place to drive improved effectiveness and efficiency (this includes areas such as Document Control, Deviations, Complaints etc).
- Responsible for Quality audit function
- Responsible for Document Control function
- Responsible for Training administration
- Responsible for Customer Complaint Management
- Authority to place products or processes on hold.
- Design and develop forms and instructions for recording, evaluating, and reporting quality data.
- Manage Corrective and Preventive Action program
- Utilize formal problem-solving techniques to resolve process-related issues.
- As required, lead cross-functional teams to support the resolution of product and/or process-related issues or objectives
- Bachelor's Degree in Science, Engineering, or a related subject.
- 5+ years of relevant supplier quality/quality operations experience in a GMP manufacturing environment in the Medical Device/Pharma industry.
- Excellent working knowledge and proven track record in all aspects of ISO13485 and FDA QSR requirements.
- Regulatory experience/knowledge.
- Good organization, supervisory, technical writing, and investigation skills are required.
What's on offer for you?
- Full family healthcare
- Pension scheme
- Annual bonus
For more information and a confidential discussion please contact Elaine Dolan.