Product Surveillance Analyst
2 days ago
Saint Paul
Job DescriptionPrimary Job Title: Product Surveillance Analyst Alternate/Related Job Titles: • Product Performance Analyst, • Complaint Investigation Specialist, • Product Experience Analyst, • Quality Systems Analyst, • Position Type: Contract, • Contract Duration: 12 months, • Start: As Soon As Possible, • Pay Rate: $31.91/hr, • Schedule: Monday–Friday, 8:00 AM–5:00 PMJob Summary:The Product Surveillance Analyst plays a critical role in managing product performance investigations and ensuring compliance with global regulatory requirements. This position involves evaluating product complaints, performing root-cause analysis, managing returned product testing, and maintaining accurate documentation in the complaint database. The role supports internal and external audits, trending, and cross-functional communication to maintain the company’s high quality and compliance standards.Key Responsibilities:, • Manage and maintain product experience investigations and associated documentation., • Receive, log, and triage incoming product experience reports., • Conduct investigations and testing of returned medical devices or components, ensuring proper documentation and safe handling practices., • Review and interpret technical product specifications, Device History Records (DHRs), and test results., • Record inspection details, condition reports, and photographic evidence for each case., • Communicate findings and request additional information from physicians, hospital personnel, and international affiliates as needed., • Independently assess whether events require Medical Device Reporting (MDR) to the FDA or other regulatory authorities., • Evaluate complaints to determine escalation requirements and ensure timely reporting., • Support internal audits, inspections, and legal requests related to product complaints., • Collaborate with cross-functional teams (Quality Engineering, R&D, Medical Affairs) to identify trends and support root cause analysis., • Contribute to Quality Management System (QMS) and Environmental Management System (EMS) compliance initiatives., • Maintain and update procedures and work instructions to reflect current practices.Required Experience:, • Bachelor’s degree in a science, engineering, or technical field., • 1–3 years of experience in product complaint handling, post-market surveillance, or medical device quality systems., • Knowledge of FDA and international regulatory reporting requirements., • Understanding of GMP, QSR, and ISO 13485 standards., • Strong written and verbal communication skills with attention to detail.Nice-to-Have Experience:, • Experience in medical device complaint management or product analysis., • Familiarity with SAP, TrackWise, or complaint handling databases., • Experience participating in regulatory audits (FDA, BSI, TUV).Required Skills:, • Product Complaint Investigation, • Root Cause Analysis, • Regulatory Reporting (MDR / Global)Preferred Skills:, • Laboratory Testing and Data Evaluation, • Cross-Functional Collaboration, • Technical Writing and DocumentationAdditional Skills:, • Device testing and product evaluation, • Complaint trending and data analysis, • Quality and compliance auditing supportBenefits:, • Medical, Vision, and Dental Insurance Plans, • 401k Retirement FundAbout the Client:Global Healthcare Innovator — A leading healthcare company dedicated to improving lives worldwide. With a diverse portfolio of medical devices, diagnostics, nutrition products, and branded generics, the organization focuses on developing groundbreaking technologies that empower people to live healthier, longer lives.Join the team and:, • Work on cutting-edge projects, • Contribute to global healthcare advancements, • Experience diverse cultures and geographies, • Discover a rewarding career with a company that caresAbout GTT:GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!Job Number: 25-27379 #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