Senior Quality Assurance Engineer

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 oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose