Quality Engineer
hace 3 días
San Diego
Job DescriptionPrimary Job Title Quality Engineer Alternate Job Titles • Validation Engineer, • Quality Assurance Engineer, • Medical Device Quality Engineer, • Process Validation Engineer, • Type: Contract, • Duration: 6 months, • Extension: Possible, • Pay Rate: $45/hr, • Provide Quality leadership in validation, design transfer, risk management, and specification development., • Author and execute validation protocols and reports (analytical methods, cleaning, processes, equipment, facilities/utilities, raw materials)., • Review and approve document change orders, development studies, and change controls., • Generate and maintain process FMEAs and risk assessments for NCEs and deviations., • Support regulatory submissions with validation documentation., • Lead and collaborate with cross-functional teams on new product introduction (NPI) and sustaining projects., • Draft and maintain master validation plans and related departmental procedures., • Participate in Material Review Board (MRB) and Production Response Team (PRT) meetings., • Propose and support process improvements using data-driven approaches., • Provide status updates and escalate issues to management as needed.Required Experience, • Bachelor’s degree in Science or Engineering., • 0–2 years in medical device, biotech, diagnostics, or pharmaceutical environments., • Experience in validation methods and process qualifications., • Knowledge of CDRH, CBER, ISO regulations (21 CFR Part 820, ISO 13485, ISO 14971)., • Familiarity with 21 CFR Part 11 and electronic document management systems.Nice-to-Have Experience, • Validation experience with custom equipment., • Statistical sampling design and risk assessment experience (PFMEA, SPC)., • Project leadership in cross-functional teams.Required Skills, • Strong knowledge of validation and quality processes., • Proficiency in MS Word, Excel, Project., • Solid problem-solving and organizational skills., • Strong cross-functional collaboration and communication.Preferred Skills, • Hands-on experience with risk-based validation approaches., • Knowledge of acceptance sampling and statistical analysis.Additional Skills, • Organized and detail-oriented., • Ability to manage multiple projects concurrently., • Excellent written and verbal communication.Physical Demands, • Ability to sit, stand, walk, kneel, stoop, or crouch as needed., • Lift/move up to 40 lbs., • Work in environments with exposure to chemicals, mechanical equipment, and moderate noise., • Occasional exposure to blood and biological materials.Benefits, • Medical, Vision, and Dental Insurance Plans #gttic #gttjobsCompany DescriptionGlobal Technical Talent is a subsidiary of Chenega Corporation () with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure. We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier. There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: Awards SIA’s Fastest Growing Staffing Firm: 2023 and 2015 SIA’s Best Staffing Firm to Work for: 2019 -2023 Inc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015 Randstad Preferred Supplier: 2020 - 2023 TechServe Alliance Excellence Award. 2019 NH Business Magazines Fast 5 fastest growing companies Ernst & Young Entrepreneur of the Year Finalist: 2015Global Technical Talent is a subsidiary of Chenega Corporation () with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure.\r\n\r\nWe are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.\r\n \r\nThere is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: \r\n \r\nAwards\r\n\r\nSIA’s Fastest Growing Staffing Firm: 2023 and 2015\r\nSIA’s Best Staffing Firm to Work for: 2019 -2023\r\nInc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015\r\nRandstad Preferred Supplier: 2020 - 2023\r\nTechServe Alliance Excellence Award. 2019\r\nNH Business Magazines Fast 5 fastest growing companies\r\nErnst & Young Entrepreneur of the Year Finalist: 2015