Senior Quality Engineer

Our client a major multinational here in Galway are looking to hire a Senior Quality Engineer on an initial 12-month fixed term contract.

The Role:

As the Senior Quality Engineer you will play a critical part in ensuring that medical device products continue to meet the highest quality and regulatory standards throughout the full product lifecycle.

Responsibilities:

• Support sustaining engineering projects by providing Design Assurance expertise to ensure compliance with global regulatory and quality standards.
• Evaluate and support the implementation of product, process, and material changes within manufacturing operations. Perform patient risk assessments related to proposed design changes.
• Provide Quality Assurance direction and technical input for qualification and validation activities in collaboration with R&D and Manufacturing Engineering teams.
• Generate and manage Design Verification protocols, and participate in the compilation and review of verification and shelf life data for regulatory submissions.
• Partner with Regulatory Affairs to ensure clear, accurate, and complete information is presented in submissions to minimize regulatory queries.
• Establish and maintain strong cross-functional relationships across R&D, Manufacturing, Regulatory, and other stakeholders in a complex technical environment.
• Stay current with evolving regulatory compliance requirements related to product design, development, and commercialization, and apply this knowledge to projects and initiatives.
• Generate and approve change requests in accordance with internal and external requirements.
• Lead investigation activities, root cause analysis, and timely resolution of quality issues related to design or process.
• Collaborate with engineering and manufacturing teams to ensure robust quality standards are implemented and maintained.
• Design or specify inspection and test methods, equipment, and quality assurance procedures. Conduct QA testing and statistical analysis as required.
• Ensure that corrective and preventive actions (CAPA) are implemented effectively and documented in accordance with regulatory and quality standards.
• May specialize in one or more quality disciplines including design, incoming inspection, production control, product evaluation, reliability, inventory control, or R&D quality support.

Qualifications:

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Minimum of 5 years' experience in a Quality Assurance or Design Assurance role within the medical device industry.
• In-depth knowledge of ISO 13485, 21 CFR Part 820, and other applicable global medical device regulations and standards.
• Demonstrated experience with design control, risk management (ISO 14971), validation/qualification activities, and root cause analysis.
• Strong written and verbal communication skills; experience interfacing with regulatory bodies is a plus.
• Proficient in statistical tools and quality methodologies (e.g., Six Sigma, CAPA, FMEA).
• Ability to manage multiple priorities and work effectively in a collaborative, fast-paced environment. xcfaprz

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.