- 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.