Quality Director

Harmonics Recruitment; Shannon; On-site; EUR 140,000 - 210,000; Full time

Job summary

Harmonics Recruitment seeks an experienced Quality Director in Shannon Co. Clare to provide strategic leadership for the quality function.

You will ensure the organisation meets regulatory requirements and quality objectives, while driving continuous improvement across all functions. The role requires extensive experience in medical device quality systems, strong communication skills and the ability to lead cross-functional teams.

Qualifications

• Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
• Minimum 15 years of quality management experience in medical device or FDA-regulated environment.
• Senior leadership experience (5–7 years).
• Lead Auditor certification and thorough knowledge of QSR/ISO requirements.

Responsibilities

• Develop and implement a comprehensive quality strategy aligned with long-term goals.
• Represent quality matters and ensure compliance with QSR, FDA, ISO and other regulations.
• Foster a culture of quality and continuous improvement across the organization.
• Lead quality improvement initiatives and projects.
• Oversee internal audits and ensure timely audits.
• Address non-conformances and escalate issues to senior leadership.
• Guide engineering, inspection and measurement processes.
• Lead problem-solving and corrective action teams.
• Review and approve CAPA actions and mentor the quality team.

Skills

Quality leadership

Regulatory awareness

Auditing & CAPA

Cross-functional leadership

Process improvement

Education

Bachelor's degree in a scientific or engineering discipline

Advanced degree preferred

Job description

Our client is seeking an experienced Quality Director to join their dynamic team in Shannon Co. Clare. The purpose of this role is to provide strategic leadership, vision, and direction for the Quality function of the company, 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 companys 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, analyse, 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.
• 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:

• Bachelors 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.

If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search.

Skills:
quality director, quality manager