This full-time, onsite role requires a hands-on leader with a minimum of three years of people management experience.

A proactive, detail-oriented approach and the ability to thrive in a fast-paced, small-team environment are essential.

Key Responsibilities

• Lead and manage the Quality team, providing mentorship, performance management, and professional development opportunities.
• Oversee and maintain the Quality Management System (QMS), ensuring alignment with ISO 13485, FDA CFR 820, and regulatory requirements.
• Ensure product quality and compliance across all stages of development and manufacturing.
• Manage quality assurance processes during in-house manufacturing and lot release.
• Investigate and resolve quality discrepancies related to product design and production.
• Collaborate with OEM contractors and vendors to uphold quality standards in component manufacturing.
• Lead process validation efforts and ensure compliance with cleanroom and sterilization protocols.
• Act as the key point of contact for regulatory audits, including FDA and Notified Body inspections, and oversee the preparation of non-conformity responses.

Ideally you will have :

• Bachelor’s degree in Engineering, Science, or a related field.
• Minimum of 5 years’ experience in the medical device industry, with a strong background in quality assurance and regulatory compliance.
• At least 3 years of people management experience, including leading and mentoring quality teams.
• In-depth knowledge of ISO 13485, FDA CFR 820, and medical device regulations.
• Experience with cleanroom operations, sterilization processes, and process validation preferred.
• Strong leadership, communication, and project management skills.

• For further information on this role please contact Regina Carroll  on 086 01 00 903 or email jobs@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

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