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Quality Control Engineer
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- Monitor the effectiveness of quality improvements and validation activities as part of the CAPA process requirements.
- Experience in Product Stewardship - engaging stakeholders from R&D, Medical Affairs, Commercial team for VOC, operations, RA etc to maintain comprehensive understanding of product performance - from manufacturability, serviceability to customer useability.
- Review sources of Quality Data including process yields and complaint data to identify any necessary CAPA activities.
- Minimum 1 year utilizing corrective and preventive action (CAPA) system, in compliance with US federal and international regulatory standards relating to medical devices.
- Process validation; statistical process control, root cause investigation, and use of problem-solving tools.
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