Advantage Technical · 6 hours ago
Quality Engineer
Arden Hills, MN
Full-time
Hybrid
New Grad, Entry Level
$37/hr - $37/hr
0+ years expAdvantage Technical is a company focused on data-driven analysis of product performance, and they are seeking a Quality Engineer. In this role, you will investigate product complaints, monitor trends, and collaborate cross-functionally to improve patient safety and enhance product performance.
Staffing & Recruiting
No H1B
U.S. Citizen OnlyHiring Manager
Damarys Zambrano, MSIOP
Responsibilities
Apply BSC’s Core Values: Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity, Winning Spirit
Review returned product lab analysis, customer feedback, and historical data to ensure proper coding and classification of complaints
Perform complaint investigations per local and global processes
Analyze post-market surveillance data for trends, patterns, and anomalies; query and bound data to support documentation releases
Respond to Competent Authority Requests
Present product performance data to management committees, design teams, and customers (directly or via sales)
Contribute to process improvement initiatives and tactical team strategies
Conduct statistical data analysis for Product Performance and Risk Management documentation
Lead or participate in cross-functional projects, including planning timelines, roles, and resources
Adapt to evolving responsibilities and new product lines
Promote a diverse and inclusive workplace culture
Qualification
Required
Bachelor's degree in Engineering, Mathematics, or related field
Internship to 3 years of relevant experience
Strong analytical and problem-solving skills; proficiency in applied statistics
Ability to manage projects independently and meet deadlines
Knowledge of quality system processes and procedures
Strong written and verbal communication skills
Passion for collaborating on a team that solves problems collectively
Must be a green card holder or US citizen
Preferred
Engineering degree with 2+ years of medical device experience
Technical understanding of medical device therapy products
Experience in Hazard Analysis, Risk Assessment, trend management, CAPA investigations, and field assessments
Strong technical writing skills
Familiarity with post-market complaint tracking, trending, and regulatory requirements
Project experience collaborating with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development, and Manufacturing
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase