Medical Device Complaint Trending Expert (Any Facility)
$81.65k - $112.7kIntegra LifeSciences Corporation
Integra LifeSciences seeks a Medical Device Complaint Trending Expert to lead end-to-end complaint data analysis and signal detection activities. The role involves designing trending methodologies, performing statistical analyses, and translating findings into actionable insights for quality, safety, and regulatory decisions across multiple facility locations.
Responsibilities
- Perform end-to-end complaint trending data analysis and identify statistically significant signals versus normal variation
- Design, maintain, and improve complaint trending methodologies aligned with regulatory and business risk principles
- Apply statistical tools and data visualization to evaluate complaint data across products, failure modes, and geographies
- Partner with Quality, Regulatory Affairs, Risk Management, and Medical Safety teams to translate trend signals into formal investigations
- Develop standardized dashboards, trend reports, and executive summaries for internal leadership and governance boards
Requirements
- Bachelor's degree in Engineering, Life Sciences, Biostatistics, Data Analytics, or related field
- 5–8 years 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 13485, ISO 14971, QMSR)
- Proficiency with statistical software or data visualization tools (Minitab, Power BI, Oracle, TrackWise)
- Advanced analytical and problem-solving skills with ability to interpret complex datasets
- Experience presenting to internal leadership and regulatory/audit stakeholders
Compensation: $81,650.00 - $112,700.00 USD base
Vacancy posted a month ago
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