Process Improvement Manager
4 days ago
The ideal candidate for this Manufacturing Engineer II position will have a strong background in manufacturing engineering and validation. They will be responsible for ensuring that manufacturing processes meet the highest standards of quality, compliance, and efficiency.
This role will involve developing and executing Test Method Validations (TMVs) to ensure the reliability and accuracy of test equipment in a medical device manufacturing environment. The successful candidate will work 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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