- Day to day management of the Quality Systems and Validation function.
- Management, coordination and development of the following processes and groups working within the function
- Management Review, CAPA, Internal Audit, Strategic Quality initiatives & Site wide CAPA Projects, Process Validation and Software Validation, Documentation Services/Packaging Graphics and Supplier Quality Assurance.
- Maintenance of the Site ISO 13485 : 2003 accreditation status.
- Compliance of Site Quality System & Validation activities to Corporate requirements and FDA, EU, MDD, TGA, PAL & CMDR regulations for Medical Devices.
- Support to and facilitation for external audits.
- Drive quality projects of major magnitude and scope.
- Provide significant guidance and approval regarding technical strategies and approaches.
- Provide guidance and training to staff, assist team members in attaining career goals, motivate individuals to achieve results, and recruit and maintain high quality staff.
- Develop and monitor department budgets and determine appropriate staff levels, schedules and resources.
- Determine project staff assignments and schedule work to meet completion dates and deliverables.
- Drive and evaluate project and department progress and results
- Drive the development of department tools and methodologies.
- Establish cross-functional team relationships & apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving technical & quality issues.
- Provide leadership role on championing best Quality practices and ensure all Corporate Quality Objectives applicable to function are met.
- Influence and define functional, departmental, Corporate and divisional policies & procedures through involvement with cross-functional initiatives.
- Complete Quality commitments as per site Quality Plan for each year and in line with corporate directives and quality strategies.
Qualifications:
- Degree in Chemical/Engineering/Sciences or equivalent
- A minimum of 9 years technical/ professional experience.
- Demonstrated Leadership and management skills with a minimum of 6 years experience within a functional management role
To apply for this opportunity please contact Maeve Lawlor in Brunel Recruitment on 051 309652 or email your cv in full to: mlawlor@brunel.ie