Excellent role for a Quality Manager to join a Medical Device company in Bray, Wicklow. This permanent role comes with a strong salary and a great chance for growth and development with a fast growing company. Process validation experience is a strong advantage.
Responsibilities
- Provide support for relevant ISO Quality Systems.
- Responsible for ensuring adherence to all company, external and appropriate regulatory requirements.
- Become a key member of the Dun Laoghaire Quality Leadership Team
- Support production personnel in relevant continuous improvement activities (Six Sigma).
- Day to day Leadership/Management of Quality Engineering Team. Manage and develop the team through involvement, delegation, and regular reviews of performance as established in goals.
- Management of Key quality systems elements relating to direct production support such as the non-conformance system, incident reporting system and customer complaint analysis.
- Management of Quality control, engineering and validations group and their activities.
- Driving key changes and improvements in the Quality assurance and control systems.
- Liaise with key external customers.
- Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments
- Prepare and Maintain documentation in compliance with appropriate regulatory requirements.
- Supporting key changes and improvements in manufacturing relating to product quality.
- GMP oversight and compliance of Production and Quality Engineering activities.
- Supporting key changes and improvements in manufacturing relating to product quality
- Any other reasonable duties which may be required by management from time to time
- A working knowledge of FDA requirements and managing FDA audits.
- Experience in process validation, Sterilisation and working in a clean room environment would be advantageous.
- Proven ability of working in a cross-functional team environment.
- Excellent interpersonal and communication skills and high level of computer literacy.