About the job
- Utilize a Risk-Based Approach to enhance Commissioning and Qualification practices in medical device manufacturing, particularly for Class II products.
- Develop and coordinate Commissioning and Qualification activities effectively throughout the manufacturing process.
- Conduct comprehensive Risk Management practices, including assessments, Functional Risk Documents, and pFMEA.
- Oversee equipment qualification and process validation to ensure compliance and efficiency.
- Implement Computerized System Validation for PLC, HMI, and related systems.
- Ensure adherence to 21 CFR Part 11 requirements by integrating them into a streamlined testing strategy.
- Support deviation investigations and resolve issues encountered during execution activities in the field.

