Quality System Engineer

Job Title: Quality System EngineerDuration: 12+ Months (Possible extension)Location: Arden Hills, MN 55112Hybrid Role (3 days a week)Responsibilities:This role does not touch product.This role will investigate product complaints and monitor client product performance.The team uses product performance data and deep dive analysis to understand if products are performing as intended.Escalating post-market field performance signals to better understand what the data is telling usCollaborating with cross functional teams to mitigate risk focusing on patient safety and improving product performance.Reviewing completed returned product lab analysis, customer feedback and historical data to identify proper coding for product complaints.Performing complaint investigations in accordance with local and global processes.Analyzing post market surveillance data for patterns and trends and investigating when necessary.May be responsible for querying & bounding data to support implementation of document releases.Responding to Competent Authority Requests.Providing input for process improvement and helping develop tactical approaches to implement team strategies.Perform data analysis for Product Performance and Risk Management documentation by applying statistical methods and software.May be asked to engage in projects/project plans outlining work plans including timelines, roles and resourcesIdentifies and leads cross-functional project teams comprised of functional experts and local managers.Investigates and reviews electronic circuits and components.Analyzes returned products to address complaints.Assist Lab Technicians during complaint investigations to ensure accurate and compliant product analysis and documentation.Review completed product analysis to ensure field allegations are adequately addressed.Education/Experience:Bachelor’s degree or higher in Electrical or Biomedical EngineeringBS with 1-3 years of relevant experience.A strong desire to be a part of a team that looks to make a difference each day to collectively solve problems.Understanding and a command of highly technical engineering topics and applied statistics.Understanding and experience operating within quality system processes and procedures.Preferred:Engineering Degree with 2-3 years of relevant medical device experience.Experience in physical device analysis.Strong technical understanding of medical device therapy products.Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.Strong Technical Writing skills.Experience with the quality system escalations, CAPA investigations, and field assessments.