Manufacturing Validation Specialist
4 days ago
We are looking for an experienced Manufacturing Engineer II to join our team at Hero Recruitment. In this role, you will be responsible for ensuring that manufacturing processes meet the highest standards of quality, compliance, and efficiency.
You will have the opportunity to develop and execute Test Method Validations (TMVs) to ensure the reliability and accuracy of test equipment in a medical device manufacturing environment. This will involve working closely with cross-functional teams to validate processes, analyze data, and drive continuous improvement initiatives.
Main Responsibilities:- 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
- Bachelor's degree in Engineering or a related technical field (or equivalent relevant experience)
- Minimum 3 years of experience in validation (Test Method Validation or Product Validation preferred)
- Strong knowledge of medical device manufacturing, regulatory standards (ISO 13485, FDA, GMP), and validation best practices
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