Quality Manager
Location: Galway (Ballybrit Business Park)
Type: Full-Time | Permanent
Reports to: COO (initially), then Quality Director
Onsite Role | Immediate Hire Required
The Opportunity
This is a newly created role in a fast-growing early-stage medical device company developing an innovative therapy for Benign Prostatic Hyperplasia (BPH). You'll join at a pivotal point – supporting both product development and manufacturing scale-up.
This role is ideal for someone with strong quality experience in medical devices who's comfortable in a hands-on, small-team environment. Someone who has previously operated at a more senior level but is happy to roll up their sleeves and take ownership again will thrive here.
Key Responsibilities
- Own and manage the company's Quality Management System (QMS)
- Report QMS performance to the Senior Management Team
- Lead and supervise Quality Engineers and Technicians
- Coordinate management reviews, quality reviews, and internal audit programmes
- Oversee supplier quality: audits, SCARs, quality agreements, and performance monitoring
- Support manufacturing validation activities: MVPs, PFMEAs, protocols, and reports
- Manage customer complaints: review reports and analyse trends
- Lead CAPA and NCR investigations and ensure timely closure
- Manage lot release and sterilisation activities
- Represent the company during FDA and Notified Body audits
- Provide hands-on QA support to Operations for quality, cost, and delivery goals
- Communicate quality expectations across all functions
- Keep the QMS aligned with evolving regulatory and business needs
Requirements
- Degree in a scientific or technical discipline
- 4+ years' experience in the medical device or pharma industry
- In-depth knowledge of ISO 13485 and 21 CFR 820
- Strong quality systems, supplier management, and validation experience
- Comfortable working across both development and manufacturing environments
- Excellent communication, organisation, and leadership skills
- Proven ability to work in cross-functional teams and hit project milestones
Why Apply
- Join a purpose-driven company at a key growth stage
- Opportunity to influence quality strategy and build on a strong foundation
- Work with a collaborative, agile, and experienced leadership team
- Flexible environment suited to someone who enjoys autonomy and responsibility
Interested?
This role is a critical hire – get in touch today to learn more or to apply.
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