Overview
Senior Quality Assurance Engineer Jobs in Galway, County Galway, Ireland at Sterling Engineering Ltd – Ireland & Europe
Title: Senior Quality Assurance Engineer
Company: Sterling Engineering Ltd – Ireland & Europe
Location: Galway, County Galway, Ireland
As a Senior Quality Assurance Engineer, you will play a key role in ensuring product quality, regulatory compliance, and effective quality system implementation across both production and New Product Development (NPD) / New Product Introduction (NPI) activities.
You will work closely with cross-functional teams to support quality processes, drive continuous improvement initiatives, and ensure products and processes meet customer, regulatory, and internal requirements.
Key Responsibilities:
- Provide Quality Assurance support across manufacturing and NPD/NPI activities, ensuring compliance with Quality Management System (QMS) requirements and applicable regulatory standards.
- Support client programmes involving the development and implementation of new products, materials, and processes, including associated quality documentation.
- Review and approve quality documentation to support pilot builds, scale-up activities and successful transfer to production.
- Conduct and support risk management activities, including DFMEA and PFMEA, ensuring effective identification and mitigation of quality risks.
- Manage and support core quality processes including CAPA, non-conformance management, change control and product release activities.
- Partner with cross-functional teams to investigate quality issues, identify root causes and implement effective corrective and preventive actions.
- Support internal, customer, and supplier audits, including the management and closure of audit findings.
- Review and approve procedures, work instructions, and quality records to ensure compliance and accuracy.
- Interface with customers and suppliers on quality-related matters, maintaining strong professional relationships.
- Support supplier quality activities, including supplier qualification and performance monitoring.
- Ensure documentation is maintained in accordance with QMS and regulatory requirements across both development and commercial operations.
- Contribute to continuous improvement initiatives aimed at enhancing product quality, compliance, and operational effectiveness.
- Support site audit readiness activities and regulatory inspections as required.
Requirements:
- Bachelor’s Degree in Engineering or a related technical discipline.
- Minimum 10 years’ Quality Assurance experience within the medical device industry.
- Proven experience supporting New Product Development (NPD) and New Product Introduction (NPI) activities.
- Strong working knowledge of ISO 13485, FDA QSR, and medical device quality system requirements.
- Demonstrated experience with CAPA, non-conformance management, change control, and quality investigations.
- Experience supporting internal, customer, supplier, and regulatory audits.
- Strong understanding of risk management principles, including DFMEA and PFMEA.
- Experience working within both development and manufacturing environments.
- Familiarity with electronic Quality Management Systems (eQMS) is advantageous.
- Excellent communication and stakeholder management skills.
- Strong organisational skills with the ability to work independently and manage multiple priorities.
For a confidential conversation about the role please apply for the role or contact Owen Clancy at [email protected] By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
