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Senior Quality Engineer

3 weeks ago

Galway, Galway, Ireland beBee Careers Full time

As a Senior Quality Engineer, you will be responsible for ensuring that our medical device products meet the highest quality and regulatory standards. This involves working closely with cross-functional teams to implement product, process, and material changes within manufacturing operations.

We are looking for someone with a Bachelor's degree in Engineering, Science, or a related technical field, and a 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 is also required.

The ideal candidate will have demonstrated experience with design control, risk management (ISO 14971), validation/qualification activities, and root cause analysis. Strong written and verbal communication skills, as well as proficiency in statistical tools and quality methodologies (e.g., Six Sigma, CAPA, FMEA), are also essential.

We offer a competitive package and opportunities for professional growth and development. If you are passionate about quality assurance and have a strong background in a similar role, we encourage you to apply.