Now Hiring: Senior Quality Engineer
Location: Galway (Ballybrit Business Park)
Type: Full-Time | Permanent
About the Company:
Our client, is a young, fast-growing med tech company working on a new and less invasive way to treat Benign Prostatic Hyperplasia (BPH), a condition affecting over 50% of men over 50. As the company grows, they're looking for a Senior Quality Engineer to support development and manufacturing efforts.
Role Overview:
As a Senior Quality Engineer, you will play a critical role in driving quality assurance activities that support product development, manufacturing, and regulatory compliance. You will work closely with cross-functional teams including R&D, operations, and suppliers to maintain and improve quality systems and processes in line with ISO and FDA regulations.
Key Responsibilities:
1. Support and maintain the Quality Management System (QMS), ensuring compliance with ISO, 21 CFR, and applicable regulatory standards.
2. Assist in the execution and coordination of internal and supplier audits, including supplier performance monitoring and quality agreements.
3. Lead investigations and root cause analyses for nonconformances (NCRs), customer complaints, and CAPAs, ensuring timely resolution and documentation.
4. Develop, review, and approve quality documentation including validation protocols, reports, and manufacturing process controls such as PFMEAs.
5. Collaborate with manufacturing and operations teams to support lot release activities, including sterilization validation and routine quality checks.
6. Participate in management reviews, quality review meetings, and data analysis to provide actionable insights for continuous improvement.
7. Provide quality input and support to internal projects and product lifecycle activities.
8. Liaise with external auditors and regulatory bodies during inspections and audits.
9. Facilitate communication of quality requirements across functional teams to ensure awareness and compliance.
10. Support updates to the QMS in response to evolving regulatory or business needs.
Qualifications & Experience:
11. Bachelor's degree in a scientific or engineering discipline.
12. 5+ years of quality engineering experience in the medical device or pharmaceutical industry.
13. Solid understanding of ISO, FDA QSR (21 CFR ), and regulatory requirements for medical devices.
14. Strong problem-solving skills with experience in CAPA, NCR, risk management, and root cause analysis.
15. Experience working with suppliers and subcontractors on quality oversight activities.
16. Excellent written and verbal communication skills, able to collaborate effectively with cross-functional teams.
17. Demonstrated ability to work independently in a fast-paced, evolving startup environment.
Apply today or reach out to to learn more.
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