Quality Assurance Engineer

2 days ago


Limerick, Limerick, Ireland Hero Recruitment Full time

At Hero Recruitment, we are seeking a highly skilled Manufacturing Engineer II to join our team. As a key member of our production department, you will play a vital role in ensuring the highest standards of quality and efficiency in our manufacturing processes.

Your primary focus will be on developing and executing Test Method Validations (TMVs) to guarantee the reliability and accuracy of test equipment in a medical device manufacturing environment. You will work closely with cross-functional teams to validate processes, analyze data, and drive continuous improvement initiatives.

  • Develop, execute, and document TMVs for test equipment per QMS and regulatory standards
  • Support the validation and implementation of medical device manufacturing processes
  • Identify and establish IQ, OQ, PQ requirements for new and existing equipment
  • Define acceptance criteria, analyze process outputs, and ensure compliance with industry standards
  • Conduct and oversee testing to validate equipment performance and reliability
  • Prepare validation protocols, reports, and other technical documentation in compliance with regulatory and quality requirements
  • Lead and contribute to validation projects, ensuring timely execution and collaboration across teams
  • Identify and implement process enhancements to improve efficiency, compliance, and product quality
  • Work closely with Quality, R&D, and Manufacturing teams to align validation activities with business needs


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