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

As Quality Manager you will be responsible for maintaining and improving the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA CFR 820, and other regulatory requirements. This role involves close collaboration with R&D, manufacturing, and regulatory teams, as well as managing and mentoring a quality team to uphold the highest standards of compliance and product quality.

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.

Develop and implement quality plans, procedures, and continuous improvement initiatives for product commercialization.

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.

Provide training and guidance to cross-functional teams on quality and regulatory best practices.

Skills & Experience

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.

Ability to work onsite in a fast-paced, small-team environment with a hands-on and problem-solving mindset.

Candidates must be eligible to work in Ireland without restriction, VISA sponsorship is not on offer at this time as this is an immediate hire for our Client.

For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie

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

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.”