This is Rohith from Intellectt INC; we've got an important role Quality Engineer II Pleasanton, CA with one of our prestigious clients. Interested candidates can please send your updated resume at

Role: Quality Engineer II

Location: Pleasanton, CA - 94588
Duration: 12 Months on W2

We are seeking a highly motivated Quality Engineer to support our Risk Management team. You will work closely with development/manufacturing/quality engineering to establish and ensure compliance and quality for product related risk management documentation. Ensure risk management assessments and evaluations for products conform to established standards and agency regulations.

WHAT YOU'LL DO

• Perform risk evaluations associated with complaints, manufacturing non-conformances and new product design activities.
• Works cross functionally with Engineering, Marketing, Manufacturing, Clinical and Regulatory to establish product risk documentation.
• Work collaboratively with operations engineering, complaint handling team, product development and design assurance.
• Understands how to comply with ISO 14971, U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments as related to risk management and product quality.
• Understands Risk/Hazard analysis, Risk Management Reports, Benefit Risk Analysis, Risk Management Planning, FMEA techniques
• Understand Hazards, Hazardous Situations, Harms, Risk Analysis/Acceptability, Risk Controls, Implementation/Verification of Risk Control
• Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
• Maintains risk documentation and establishes procedures that affect the department.
• Ability to perform gap analysis between standards/procedures and in use documentation