Senior Quality Assurance Engineer

Job Title: Senior Quality Assurance Engineer

Location: Irvine, CA

Type: Contract

Compensation: $65-73/hr

Work Model: Onsite

Responsibilities
• 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.

Requirements
• 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.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific