Lead Post Market Surveillance Specialist

• Serves as the process owner and subject matter expert for BSHS post market quality complaint trending and related product surveillance review activities. 

• Establishes the strategic direction, governance framework, methodologies, and performance measures for post market surveillance trending. 

• Leads complaint trending and PMSRB activities across the BSHS product portfolio, ensuring consistent application of methodologies and effective evaluation of product performance throughout the product lifecycle. 

• Partners with cross-functional stakeholders to ensure trending outputs are appropriately incorporated into quality system processes, including risk management, CAPA, regulatory reporting, management review, field actions, and product improvement activities. 

• Owns the statistical methodologies, normalization approaches, signal detection criteria, escalation thresholds, and decision rules used to identify adverse trends and emerging product quality signals. 

• Develops, validates, and continuously improves scientifically sound and statistically defensible approaches for complaint trending and signal evaluation. 

• Evaluates and implements enhanced surveillance approaches including alert limits, alarm limits, leading indicators, predictive monitoring, and other proactive signal detection methodologies. 

• Assesses the effectiveness of existing trending rules and analytics capabilities to improve sensitivity, specificity, and timeliness of signal detection. 

• Serves as the organization's subject matter expert for complaint trending methodology, statistical analysis, and signal detection. 

• Owns identification, prioritization, and closure of gaps identified within complaint trending processes, methodologies, governance mechanisms, systems, and analytics capabilities. 

• Leads development and execution of improvement roadmaps that strengthen signal detection effectiveness, advance program maturity, and improve overall surveillance capabilities. 

• Serves as the accountable owner for trending-related remediation activities, including root cause analysis, implementation of corrective actions, verification of effectiveness, and long-term sustainability. 

• Develops reporting, analytics, and business intelligence solutions that improve visibility into product performance, surveillance effectiveness, and emerging risks. 

• Provides technical leadership, mentoring, training, and consultation on trending methodologies, signal evaluation, surveillance governance, and post-market analytics while supporting audits, inspections, and management reviews. 

• Bachelor's degree required 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. 

• Experience supporting CAPA, quality remediation, process improvement, or quality system transformation initiatives strongly preferred. 

• Experience with Power BI, SQL, Minitab, Tableau, or similar analytical tools strongly preferred. 

• 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. 

The annualized base salary range for this role is $116,300 - 182,000  and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.