Quality Engineer

Company : Katalyst Healthcares & Life Sciences

Summary

The Quality Engineer will be responsible for the execution and tracking of daily production support activities regarding all aspects of product quality as well as provide support for site projects.

Roles & responsibility

• Perform risk assessments for ERs (nonconformances / CAPAs), Change Controls. Etc.
• Act as internal consultant to various departments and teams for current interpretation of GMP/ISO/QMS.
• Review equipment validations to support ad-hoc limited qualifications, new equipment qualifications, equipment and facility requiring re-qualifications, calibrations, etc. Ensure appropriate qualifications activities are performed and documented in compliance with GMPs, GTPs, and GDPs. Review and approve validation documents in Maximo system, including remote off-shift review as required.
• Review and approve documents under Change Control ensuring compliance with GMP, GDP, GTP, and regulatory standards such as ISO13485, 21CFR820, ISO14971, etc.
• Support the Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Field Action, etc. Update risk management file documents as needed.
• Provide Quality support on project work and lead projects related to core production as well as future process improvement projects, new product/process launches, etc., while ensuring compliance with applicable regulations/standards. Challenge the approach and provide innovative alternative solutions to protocol designs. Lead project activities related to Quality and Compliance such as Quality Plans.
• Provide guidance and direction on ER (Client and CAPA) investigations. Complete ERs and Change Controls as required. Ensure record compliance to all appropriate regulatory standards. Provide a compliant path forward on complex issues.
• Recommend enhancements / continuous improvements to the Quality Management System and QMS procedures.

Education and Experience

• Bachelor's degree required in Engineering or Science, or minimum of 6 years of experience working in a technical field with higher level responsibilities
• Minimum 3 years of Quality Assurance, Quality Control, Quality Engineering, Engineering, IT Compliance, or Operations experience
• Risk Management experience preferred
• CAPA lifecycle experience, including root cause investigation
• 21CFR820 and 1271
• Technical writing
• Basic statistics
• Presentation and communication skills
• GMP, GDP, GTP understanding
• Change Control experience
• Validation lifecycle experience helpful but not required
• Audit support experience helpful, but not required

Apply Online