Our highly regarded manufacturing Client based in Shannon has a requirement for a Quality Director.
This is a strategic role which will involve approx 20% European travel to Customer sites.
REPORTING TO: CEO
JOB PURPOSE: To provide strategic leadership, vision, and direction for the Quality function ensuring the organisation meets and exceeds its business and quality objectives.
PRINCIPAL ACCOUNTABILITIES: Strategic Leadership Develop and implement a comprehensive quality strategy aligned with the company's long-term goals.
Act as the primary representative for all quality-related matters, ensuring compliance with QSR, FDA, ISO, and other pertinent regulations.
Foster a culture of quality and continuous improvement across the organization.
Lead the development and execution of quality improvement initiatives and projects.
Regulatory Compliance and Quality Systems Ensure the quality management system is robust, effective, and compliant with all relevant standards and regulations.
Oversee the internal audit process, ensuring thorough and timely audits.
Identify, analyze, and address non-conformances and trends, escalating issues to senior leadership, as necessary.
Promote awareness of regulatory and customer requirements throughout the organization.
Operational Excellence Provide technical guidance and support for engineering, inspection, and measurement processes.
Oversee preventive maintenance and calibration systems to ensure optimal performance.
Lead the scrap analysis process and drive initiatives to reduce waste.
Participate in and lead problem-solving and corrective action teams.
Review and approve CAPA actions, ensuring alignment with quality systems.
People Leadership Mentor and develop the quality team, fostering a high-performance culture.
Support the training management process, ensuring staff are well-equipped to meet quality standards.
Collaborate with cross-functional teams to drive business success and compliance.
KNOWLEDGE/EXPERIENCE: Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
Minimum 15 years of quality management experience in the medical device industry or FDA-regulated environment.
Proven experience in a senior leadership role (at least 5 to 7 years).
In-depth knowledge of Quality Assurance and regulatory requirements.
Exceptional communication skills, with the ability to engage and influence all levels of the organization.
Strong analytical and problem-solving abilities.
Demonstrated success in leading cross-functional teams and driving organizational change.
Thorough knowledge of QSR and ISO quality system requirements.
Lead Auditor certification.
Highly Experienced in medical device operations, with a strong background in QA and people management.
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