Post Market Quality Specialist 3

Essential Duties and Responsibilities

• Perform routine and ad hoc analysis of complaint and post market data for assigned product families
• Identify trends, anomalies, and early warning signals using statistical methods and established KPIs
• Extract and validate complaint data to support Product Quality Engineers (PQEs), Quality Design Engineers (QDEs), and cross functional investigation teams
• Conduct “as reported vs. as analyzed” complaint code reconciliation to ensure accurate surveillance insights
• Own, schedule, prepare, and present BU level Post Market Surveillance Review Boards
• Summarize key complaint trends, signals, KPIs, and actions required for follow up
• Ensure PMS RB records are accurately documented and released in PLM in a timely manner
• Support product investigations in partnership with PQEs and QDEs, providing data analysis, trending support, and preliminary signal assessment
• Provide rapid complaint data inputs for emerging issues, field escalations, and early investigations
• Perform queries and generate trend analyses for CAPA inputs, Health Risk Assessments (HRAs), and cross functional assessments
• Supply complaint data for PMS Plans, PMS Reports, PSURs, and Canadian Summary Reports, as requested
• Provide complaint data to support PMCF and Clinical Evaluation documentation
• Maintain surveillance trackers, templates, and other PMS documentation tools to ensure accuracy, consistency, and compliance
• Compile and report weekly and monthly surveillance metrics and KPIs to support Quality leadership
• Partner closely with PQEs, Product Support, QDEs, and other key functions to ensure consistent complaint coding, accurate data interpretation, and alignment on findings
• Support cross functional discussions on product performance, emerging risks, and needed follow up actions
• Recommend and implement improvements to complaint coding, data quality, PMS processes, and analytical workflows
• Support alignment of divisional PMS processes with corporate standards and data governance expectations
• Contribute to internal and external audits/inspections by providing accurate complaint data and documentation support

Qualifications

• Bachelor’s degree in Engineering, Science, or related technical field
• Experience: 5+ years in post market quality, complaint handling, quality engineering, or similar analytical role. Medical device experience preferred
• Skills: Strong analytical and statistical skills; experience identifying trends and early warning signals; working knowledge of FDA 21 CFR 820.198, ISO 13485, ISO 14971, and EU MDR PMS requirements; strong communication skills for presenting data to cross functional teams and leadership; effective organization, prioritization, and problem solving skills; computer skills: Microsoft Office, Minitab, Oracle, Agile and Salesforce (H1)

Pay

The annualized base salary range for this role is $92,200 - $144,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.