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Quality Engineer III

1 month ago

Fremont, United States Akraya Full time

Primary Skills: Quality Assurance, Product Validation, CAPA investigation, DFMEA & PFMEA, ISO/FDA/IVDR/QSRJob Title: Quality Engineer IIIDuration: 12+ monthsContract Type: W2 onlyLocation: Fremont, CA - 94538 (Onsite)Pay Range: $51.50 - $56.50 Per Hour#IND1JOB RESPONSIBILITIES:We are searching for a skilled Quality Assurance Engineer with expertise in medical devices to ensure our products meet all quality standards and regulations throughout the design and development process. This role involves leading quality assurance activities for new product development, including designing and implementing test plans and protocols, supporting product design improvements, and managing product lifecycle quality aspects. The successful candidate will work closely with internal stakeholders, including research and development, operations, and supply chain teams, to improve product designs and processes.JOB REQUIREMENTS: Lead and support new product development projects, ensuring compliance with quality management systems and regulatory standards. Manage quality issues, process improvements, and risk updates related to operations. Supervise pre- & post-production design assurance and quality engineering activities. Review, approve, and ensure the accuracy of validation protocols, reports, and supplier quality. Coordinate the resolution of quality assurance issues, lead CAPA investigations, and support quality engineering for product investigations.Must-Have Skills: Bachelor's degree with a minimum of 7 years of experience in medical device quality assurance. Strong capability in product/process validation, software validation, test method validation, and utilizing risk management tools. Exceptional documentation, process orientation, and analytical skills with an aptitude for translating data into actionable insights.Schedule: M-F 8am-5pm, Fully onsiteABOUT AKRAYAAkraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a positive work environment. Voted the #1 Best Place to Work in Silicon Valley (2023) and a Glassdoor Best Places to Work (2023 & 2022), Akraya prioritizes a culture of inclusivity and fosters a sense of belonging for all team members. We are staffing solutions providers for Fortune 100 companies, and our industry recognitions solidify our leadership position in the IT staffing space. Let us lead you to your dream career, join Akraya today