Our client, a leading medical device company in Galway, are looking to recruit a Quality Systems Director. The successful candidate will report to the VP of Operations & Supplier Quality. The Quality Systems Director will be responsible for promoting continuous improvements and instilling organisational leadership.
- Providing overall Quality leadership for the site by establishing a clear vision and strategic direction for Quality that assures customer satisfaction, regulatory compliance and drives continuous improvement
- Contribute to overall site strategic and tactical direction as a member of the Senior Leadership Team
- Provide critical input and influence as a staff member of multi-site operations quality team
- Leadership of the site quality function ensuring the development, engagement and retention of a strong pipeline of Talent to ensure capability in line with current and future needs.
- Establish the site quality plan and objectives, ensuring all activities are conducted in accordance with the requirement of the Quality System and applicable external regulatory body requirements.
- Champion the First Time Quality Principle to improve our internal and external product quality performance
- Participate in the innovative application of business process improvement opportunities across site
- Leverage the cell operating system and other Lean principles to improve effectiveness and efficiency of all quality processes and services
- Participate as member of the Cardiac and Vascular Group site quality leaders forum to influence the development and improvement of the shared quality system
- Ensure that the quality system assures product quality and regulatory compliance by predictably and consistently detecting and correcting deficiencies
- As designated management representative, ensure execution of site quality management review
- Ensure effective preparation and execution of all external regulatory agency site inspections and communications
- Influences the product development process through the core team and has responsibility for effective transfer validation to operations to assure product quality and regulatory compliance
- Ensure post market surveillance of site products is operating effectively through business partners.
- Manages Quality Assurance systems and programs to ensure acceptance and monitoring of material, equipment and environment used to manufacture product from plant through sterilisation and release to distribution
- Clear understanding of Quality System Regulations (QSR), design control, ISO 9001 standards, ISO 13485:2003, European MDD regulation and Japan PAL regulation
- Knowledge of FMEA, health hazard analysis, reliability analysis, process validations, software validations, DOE, SPC, process capability techniques and other quality tools.
- Must have an in-depth understanding quality systems, business process improvement tools, manufacturing and processing principles.
- Bachelor's degree in Engineering, Sciences or related medical/scientific field is required. Masters preferred.
- 10+ years' relevant industry experience with at least 5+ years people management experience
- Experience in medical device or related industry.
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