[ref. c47759904] Galway - Senior Quality Engineer New
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 13485 and FDA regulations.
Key Responsibilities:
- Support and maintain the Quality Management System (QMS), ensuring compliance with ISO 13485, 21 CFR 820, and applicable regulatory standards.
- Assist in the execution and coordination of internal and supplier audits, including supplier performance monitoring and quality agreements.
- Lead investigations and root cause analyses for nonconformances (NCRs), customer complaints, and CAPAs, ensuring timely resolution and documentation.
- Develop, review, and approve quality documentation including validation protocols, reports, and manufacturing process controls such as PFMEAs.
- Collaborate with manufacturing and operations teams to support lot release activities, including sterilization validation and routine quality checks.
- Participate in management reviews, quality review meetings, and data analysis to provide actionable insights for continuous improvement.
- Provide quality input and support to internal projects and product lifecycle activities.
- Liaise with external auditors and regulatory bodies during inspections and audits.
- Facilitate communication of quality requirements across functional teams to ensure awareness and compliance.
- Support updates to the QMS in response to evolving regulatory or business needs.
Qualifications & Experience:
- Bachelor’s degree in a scientific or engineering discipline.
- 5+ years of quality engineering experience in the medical device or pharmaceutical industry.
- Solid understanding of ISO 13485, FDA QSR (21 CFR 820), and regulatory requirements for medical devices.
- Strong problem-solving skills with experience in CAPA, NCR, risk management, and root cause analysis.
- Experience working with suppliers and subcontractors on quality oversight activities.
- Excellent written and verbal communication skills, able to collaborate effectively with cross-functional teams.
- Demonstrated ability to work independently in a fast-paced, evolving startup environment.
Apply today or reach out to [email protected] to learn more.
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