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Quality Engineer - I (Audit/ Compliance/ GMP/ ISO)

LanceSoft INC
Irvine, California, United States
April 20, 2019


• Provides overall quality assurance leadership In the management of select contract manufacturing sites engaged In the production of products. Conducts audits to good manufacturing practices, International organization for standardization and any other applicable standards.

• Supports established contract manufacturing sites via conducting audits, driving compliance and quality Improvement Initiatives.

• Assists In the resolution of process and product nonconformance events. Collects and escalates product or process complaints.

• Calculates contract manufacturer performance metrics and assists In conducting management reviews.

• Prepares audits of all quality system categories to assess compliance to process excellence standards. Implements basic measurement systems to monitor effectiveness of quality and reliability systems to Identify, bracket, correct and prevent defects, demonstrating continuous Improvement to management.

• Assists In technical Issues for manufacturing processes that are to be transferred to satellite facilities.