Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
The overall position is to support regulatory and agency inspections, audits, investigation, and inquiries regarding product design and manufacturing quality. Review the adequacy and correctness of changes to Bill of Materials, Assembly procedures, Drawings, Component specification, FMEAs, and Control Plans.
Requirements:
- Initiating and implementing cost improvement plans on new and/or existing programs.
- Perform Validation (IQ, OQ, PQ), in accordance with company's SOP's.
- Contribute to the design and development of components, assemblies and devices.
- Manage process validation activities for development programs.
- Participate in CAPA activities.
- Understanding Data analysis and trend analysis in complaints, supplier quality, non-conforming materials, training and root cause analysis.
- Working with suppliers, management, engineers, and manufacturing to resolve quality problem.