Senior Quality Assurance Engineer

Senior Quality Assurance Engineer

Location:

Irvine, CA Type:
Contract Compensation: $65-73/hr Work Model:
Onsite

• Perform validation, supplier quality, risk management, and mitigation activities as part of GQO Quality Assurance operations.
• Collaborate effectively with project teams, NPI team, and cross-functional stakeholders to ensure quality standards are met throughout the product lifecycle.
• Lead or support various quality assurance activities, including process validation, supplier quality assessments, and risk management practices aligned with ISO 14971.
• Drive continuous improvements in inspection strategies, implementing lean inspection methods and optimizing inspection costs without compromising product safety and reliability.
• Facilitate First Article Inspection (FAI) strategies and approve inspection reports.
• Support design and process transfer activities and mentor teams on quality best practices.

• Previous experience in medical device industry
• Bachelor's degree in Engineering or related field; advanced degree (M.S.) preferred.
• Minimum of 3 years of professional experience post-academia.
• Proficiency with Trackwise and Minitab systems is highly preferred.
• Strong knowledge of risk management, validation, and inspection processes.
• Excellent collaboration and communication skills, with a focus on cross-functional teamwork.

: #558-Scientific