Lead Post Market Surveillance Specialist
$116,300–$182,000 year
On-siteNewark, Delaware, United States
Job Summary
Own the strategic direction, governance framework, and statistical methodologies for BSHS post-market complaint trending and signal detection. Establish standards for emerging product quality risks, evaluate analytics capabilities, and drive improvements in sensitivity and timeliness. Lead cross-functional remediation activities with Product Quality Engineering, Regulatory Affairs, and Corporate Quality to close process gaps and implement sustainable corrective actions. Provide technical leadership, mentor personnel, and develop business intelligence solutions to enhance surveillance effectiveness across the product portfolio.
Required Qualifications
- Bachelor's degree in Engineering, Statistics, Mathematics, Data Analytics, Quality, Life Sciences, or a related technical discipline
- 8+ years of experience in medical device, healthcare, life sciences, or another regulated industry
- Demonstrated experience leading complaint trending, surveillance analytics, quality data analysis, or signal detection processes
- Experience establishing or improving statistical methodologies, surveillance systems, or quality analytics programs
- Advanced knowledge of statistical process monitoring, signal detection, trend analysis, and surveillance methodologies (e.g., standard-deviation-based criteria, sampling per ANSI/ASQ Z1.4)
- Demonstrated experience developing, challenging, and improving trending methodologies rather than solely executing established analyses
- Strong understanding of complaint handling, post market surveillance, CAPA, risk management, and regulatory requirements (e.g., 21 CFR 820, 21 CFR 803, EU MDR Article 85, UK Post-Market Surveillance Requirements)
- Strong proficiency with statistical analysis, exploratory data analysis, data visualization, and business intelligence tools (e.g., Power BI, SQL, Tableau)
- Ability to identify quality system gaps, establish improvement roadmaps, and lead implementation of sustainable solutions
- Demonstrated ability to evaluate complex quality system issues and develop practical, risk-based solutions balancing compliance, patient safety, product quality, and business objectives
- Strong facilitation, communication, and influencing skills; ability to communicate complex data clearly across all levels of leadership without direct authority
- Strong technical writing and documentation skills
- Ability to provide organizational leadership and strategic direction without formal supervisory responsibility
Desired Qualifications
- Experience supporting CAPA, quality remediation, process improvement, or quality system transformation initiatives
- Experience with Power BI, SQL, Minitab, Tableau, or similar analytical tools
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