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Quality Engineer, Risk Management

USDM Life Sciences is a leading global regulatory compliance and technology firm with 20 years of experience offering bold solutions that accelerate innovation, compliance, and performance in life sciences. We are currently seeking a Quality Engineer skilled in Risk Management to support our Pharmaceutical company client based in Santa Monica, California. This is an exciting opportunity with a company making massive progress in the cell therapy world.

Quality Engineer, Risk Management Job Description  Responsibilities (include but are not limited to): 

• Provide in-depth understanding and application of quality risk management practices and approaches in design and manufacturing environments;

• Demonstrate intimate working knowledge of relevant standards, principles and best practices (i.e. ICH Q9, Quality Systems)

• Demonstrate the ability to facilitate cross functional teams 

• Demonstrate working knowledge of quality risk management tools, including FMEA, PHA, RR&F

• Work with project teams and necessary departments (e.g. manufacturing, engineering, product development, quality control, supplier quality, supply chain, etc) to complete risk assessments.

• Leads teams in identifying mitigations and ensuring traceability of identified mitigations.

• Evaluate product data (e.g. process and/or product changes, deviations, CAPAs, complaints, etc) for their impact to the current quality risk management files.

• Creating and writing quality risk management plans, reports, and risk assessments.

• Report status and progress of quality risk management activities or projects to management

• Track, review and report metric information 

• Support Quality Engineering efforts as appropriate. 


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