5-8+ years of medical device complaint handling or post-market surveillance experience.
Strong working knowledge of 21 CFR Part 820, Complaint Files (198), 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR, and medical device quality systems.
Demonstrated experience independently evaluating, investigating, documenting, and closing complex medical device complaints.
Experience supporting adverse event reporting, complaint investigations, CAPA activities, complaint trending, risk assessments, and regulatory decision making.
Strong data analytics skills with demonstrated experience analyzing large and complex datasets to identify trends, detect emerging signals, assess risk, and support data-driven quality and regulatory decisions.
Experience utilizing statistical analysis, data visualization, reporting methodologies, and analytical tools to evaluate complaint data, product performance, and post-market surveillance metrics.
Advanced proficiency with Microsoft Excel, including pivot tables, advanced formulas, Power Query, data modeling, and data analysis techniques.
Experience working with SQL, databases, Salesforce, complaint handling systems, electronic quality management systems (eQMS), and business intelligence or reporting tools.
Experience developing, maintaining, and interpreting quality metrics, dashboards, and performance reporting for management review and continuous improvement activities.
Strong technical writing
Documentation
Data analysis
Eligible to work with any employers without sponsorship