Senior Quality Assurance Engineer
Joulé · Irvine, CA · 2 mo ago
Engineering$65–$73/hrContract
Location: Irvine, CA • Contract • 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 the 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.
Pay
$65–73 per hour
Benefits
- Medical, dental, and vision coverage.
- Spending accounts.
- Life insurance and voluntary plans.
- 401(k) plan participation.