Quality Manager Ostomy Plant
Our client, a medical device company in Mayo are currently looking to recruit a Quality Manager Ostomy Plant for their site.
- The Quality Assurance Manager provides Quality leadership for the Ballina Ostomy Plant, and contributes to the growth and profitability of the company.
- These provisions include the necessary monitoring, feedback and corrective action mechanisms to ensure continued compliance to both system provisions as well as product (device) requirements.
- Lead and develop the Ostomy Quality Team
- Develop and advise on the continued development of quality systems and procedures for the Ostomy area, including the development of product specifications / drawings / quality plans in conjunction with NPC personnel and the development of Master Validation Plans as required.
- Provide leadership in change management and risk assessment, specifically process risk and capability analyses
- Conduct, lead, or direct Ostomy product complaint investigations.
- Coordinate the Ostomy business Corrective and Preventive Action (CAPA) program
- Participate in the internal audit program
- Provide project leadership for implementing continuous improvement projects
- Provide leadership and resources for verification and release of finished goods into distribution
- Ensure Ostomy Quality team is trained to FDA QSR and ISO 13485 / 14971 requirements
- Personnel Staffing and Management
- Problem Solving and Analysing
- Project Managing (includes AFE process)
- Fiscal Managing (includes budget preparation)
- Goal Setting
- Processes Improvement
- Degree in Physical Science, Engineering, or other related discipline
- 10 years' experience in a quality engineering/systems role including people management experience.
- Knowledge of applicable foreign and domestic regulations
- Knowledge of quality engineering tools and statistical quality control techniques
- Knowledge of quality auditing techniques
- Knowledge of process validation techniques
- Knowledge of project management skills
- Basic knowledge of sterilization
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