Overview
Quality Engineering Manager Jobs in Galway Metropolitan Area at HERO Recruitment
Title: Quality Engineering Manager
Company: HERO Recruitment
Location: Galway Metropolitan Area
We are seeking an experienced Quality Manager to lead and oversee quality assurance activities across product development, manufacturing, and commercialization for a scaling Medical Device Company in Galway.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.
