Medical Device Complaint Trending Expert; Facility

The Medical Device Complaint Trending Expert is responsible for the end-to-end development, execution, and oversight of complaint data trending and signal detection activities to ensure timely identification of product quality, safety, and compliance risks. This role serves as a subject matter expert (SME) for complaint analytics, statistical trending methodologies, and regulatory expectations related to post-market surveillance. The individual partners cross-functionally with Quality, Regulatory Affairs, Risk Management, R&D, Manufacturing, and Medical Safety to translate complex complaint data into actionable insights that support corrective and preventive actions (CAPA), regulatory submissions, and risk management decisions.

• Work end to end complaint trending data and analysis
• Identify trends within complaints and differentiate between variation and signal
• Design, maintain, and continuously improve complaint trending methodologies aligned with regulatory and business risk principles
• Perform routine and ad hoc trending analyses to identify statistically significant signals, emerging risks, and adverse trends
• Apply appropriate statistical tools and data visualization techniques to evaluate complaint data across products, failure modes, and geographies
• Establish alert thresholds, escalation criteria, and signal validation processes
• Support inspections and audits with defensible trending analyses and documentation
• Author or review SOPs, work instructions, and templates related to trending and post-market surveillance
• Partner with Complaint Handling, CAPA, and Risk Management teams to translate trend signals into formal investigations and actions
• Collaborate with Medical Safety, Clinical, and Regulatory teams to evaluate patient safety and reporting impact
• Present trending results and risk assessments to management, governance boards, and quality review councils
• Serve as SME for complaint data systems and analytics tools (e.g., validated QMS systems, dashboards, and reporting platforms)
• Ensure data integrity, consistency, and traceability across complaint datasets
• Develop standardized dashboards, trend reports, and executive summaries
• Interpret and analyze complex data sets and clearly communicate findings to both technical and non-technical stakeholders
• Monitor industry best practices and regulatory guidance related to complaint trending and post-market surveillance
• Identify process improvements to enhance early signal detection, efficiency, and compliance
• Mentor and train colleagues on trending methodologies and regulatory rationale

• Bachelor’s degree in Engineering, Life Sciences, Biostatistics, Data Analytics, or a related field
• Minimum 5–8 years of experience in medical device quality, complaint handling, post-market surveillance, or safety analytics
• Demonstrated expertise in complaint trending, signal detection, and root cause analysis
• Strong knowledge of global medical device regulations (FDA, EU MDR, ISO standards)
• Advanced analytical and problem-solving skills with the ability to interpret complex data
• Excellent written and verbal communication skills
• 21
  
  CFR Parts
  803 and
  820 / QSR and QMSR EU MDR (Articles
  83-86) MDSAP and experience
• Experience presenting to internal leadership as well as regulators/auditors

• Advanced degree (MS, MBA, or equivalent)
• Proficiency with statistical software or data visualization tools (e.g., Minitab, PowerBI, Oracle, Track Wise)
• Experience working with global complaint databases and high-volume product portfolios
• Strong oral and written English communication skills and effective interpersonal skills
• Experience in FDA-regulated environment
• Strong collaboration skills and experience working in a…