Kelly Services are recruiting for a County Wicklow based medical diagnostic company who are seeking to hire a Head of Quality to join their senior leadership team. Reporting to the Corporate Vice President of Quality and Regulatory, the Head of Quality is accountable for leading all aspects of Quality to ensure product quality and customer satisfaction.
- Lead the following functions within the Quality Department at the Bray, Ireland site: P
- Product Quality Assurance and Customer Support
- Quality Engineering
- Quality Systems
- Product Release
- Document Control
- With 3-5 direct reports, manage 25+ departmental personal in the context of a data-driven, goal-oriented performance culture; ensure headcount is correctly resourced
- Maintain an effective Quality Management System that complies to international standards and regulations.
- Be a key member of the Site Leadership Team
- Understand new regulations and guidelines and implement systems and procedures to incorporate these new regulations.
- Establish, manage and achieve Key Performance Indicator quality goals
- Lead Management Review process; report on the performance of the Quality System
- Manage Design Control, Change Control, CAPA, Risk Management, Product Vigilance and Document Control Systems
- Lead strategic quality improvement projects and initiatives which enhance long-term sustainability, including technology transfer and process improvement projects
- Evaluate, and authorize if appropriate, changes to the manufacturing and supply chain processes
- Approve product labels, package inserts and Marketing material
- Lead product and facility inspections, preparation of procedures and instructions including certification assessment and surveillance audits, FDA, HPRA, WHO inspections, other regulatory inspections and supplier audits
- Process, equipment, software and facility validations
- Coordinate Product Safety Notifications / Product Field Actions as well as Medical Device Reporting (MDR) with Regulatory Affairs
- ISO 13485 Management representative, manage all correspondence with Notified Body
- International travel (up to 20%) may be required
Qualifications / Experience
- Primary degree qualification in a science, engineering or business discipline
- Minimum 10 year experience in in vitro diagnostics or similar industry.
- Project management of change programs
- Global regulatory audits / inspections with HPRA / WHO /FDA and Notified body
- Maintaining all aspects of Quality Management System
- Successful implementation of continuous improvements to QMS
- Building and leading effective teams, and highly motivated individuals
- Effective communications with senior management
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.