Head of Quality
|Job Title:||Head of Quality|
|Location:||Republic of Ireland,|
|Salary:||€90000 - €120000 per annum|
|Contact Name:||Rachel Radford|
|Job Published:||December 19, 2016 18:18|
My client, a Medical Devices facility, are currently recruiting for a Head of Quality to join their team.
Reporting to the Chief Scientific Officer, the Head of Quality and Product Safety is accountable for leading all aspects of Quality to ensure product quality and customer satisfaction.
- Lead the following functions within the Quality and Product Safety Department:
- Product Quality Assurance and Customer Support
- Quality Engineering
- Quality Systems
- Product Release
- Supply Chain Quality and Internal Audit
- Document Control and Training
- With 3-5 direct reports, manage 20+ 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
- Understand new regulations and guidelines, as they apply to the company, 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 the long-term sustainability of the company, 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 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
- Member of the Operations Management Team and Corporate Quality Team
- ISO 13485 Management representative
- 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 Medical Devices
- Project management of change programs
- Global regulatory audits / inspections
- 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
Skills and Behaviours
- Excellent verbal and written communication skills
- In-depth knowledge of International Standards, GLP and GMP
- Ability to manage complex projects involving multiple functions
- Ability to gain consensus for key Quality/Operational decisions
- Strong analytical/problem-solving skills
- Ability to collaborate with and influence groups in a positive, team‑based environment both at local and global sites
- Work with a sense of urgency and have the ability to be impartial and objective
- Be an active learner; ability to mentor and develop others
- Hold reports and cross-functional team members accountable
Key Success Factors
- Actively listens and shares information and knowledge with others in a timely manner. Ensures that appropriate information is disseminated, received, and understood.
- Takes a long-term view of the business to create a vision for the Quality organisation. Formulates and implements effective strategies to achieve that vision.
- Understands the business, industry, market trends, consumers, and competitors and translating this knowledge into opportunities, strategies, decisions and actions.
- Plans, organises, and prioritises resources and activities. Achieves results through optimal approaches.
- Provides clear direction; delegates and empowers others to achieve results. Develops others to improve individual and team performance.
- Demonstrates the flexibility and adaptability to be successful in a changing environment. Proactively seeks and is open to alternative ideas and approaches.
- Shows enthusiasm and a strong commitment to the organisation. Is resilient and determined to seek out and to meet challenges.
- Develops relationships inside and outside of the business to enhance personal and company effectiveness.
- Takes the initiative to search for new ideas and improvements for the business. Develops and implements new and unique solutions to improve products and processes and create competitive advantage for the company.
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