I currently have an immediate opening for a Head of Quality with a world leading medical device company based in Cork.
This is a fantastic opportunity to join an excellent company with an excellent culture as they continue to grow.
Reporting externally to the Vice President of Global Quality Operations. This role is responsible for providing strategic direction and exceptional leadership to create a world-class quality function at the company's Manufacturing facility.
The successful candidate will have strong leadership experience, the ability to manage a large quality team, and the skills necessary to build strong relationships with external stakeholders. The Site Head of Quality manages and directs the Quality Department to ensure that all product manufactured complies with applicable regulatory and company requirements. They are responsible for the development, direction, and engagement of quality professionals to support the business in meeting its objectives. They will act as the Management Representative for the site.
1. Participate as a full member of the site leadership team, helping to define site strategy and objectives.
2. Perform the duties as Management Representative in accordance with FDA and ISO requirements to ensure the overall Quality System is implemented and effective
3. Ensure that processes needed for an effective quality management system are established and implemented. Maintain facility compliance to FDA Quality System Requirements, ISO 13485 and Health Authority requirements (as applicable). Guide the site through the implementation of EU-MDR.
4. Drive process improvements with the use of recognized quality tools, internal audit program, appropriate CAPA systems and feedback systems (complaints etc.). Deliver programs and processes that drive optimal quality throughout the manufacturing process.
5. Hire appropriately skilled quality professionals and provide strong leadership and development opportunities to enhance the talent pipeline for the site. Manage and maintain a suitably resourced QA department to support the manufacturing site needs over three shifts.
6. Promote a strong quality culture and behavior through regular site communications. Instill a high morale within and across departments and promote cooperation and teamwork.
7. Communicate the site Quality Performance and any need for improvement or escalations to the site leadership team and VP of Global Quality operations.
8. Implement systems and controls to prevent product recalls and manage post market surveillance actions in accordance with regulations and corporate requirements.
9. Ensure continual Quality System compliance by adherence to established and evolving regulations and business requirements.
The Ideal Candidate will have:
* Exceptional leadership skills with a high level of strategic, organizational and communication skills are essential
* Proven experience in quality assurance strategy, supplier development, metrics, scorecards, and partnership level alliances
* Strong knowledge of appropriate Regulations and Standards.
* Ability to lead and engage a large group of people with varied qualifications and very diverse responsibilities
* Strong skills in developing relationships with a variety of departments, facilities and regulatory bodies both National and International
Minimum: Bachelor Degree in Engineering or relevant Science discipline.
Preferred: Master's Degree in Engineering or related Science discipline and business qualification.
Alternative combination: Advanced education in a relevant technical field may be substituted for some experience.
If you are interested in hearing more about this excellent opportunity please respond directly to this advert for immediate consideration.
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