Hologic

Develops medical devices for early detection

Lead Post Market Surveillance Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeNewark, DE, USAIn-person

About the Job

Requirements

A bachelor's degree in Engineering, Statistics, Mathematics, Data Analytics, Quality, Life Sciences, or a related technical discipline is required.
At least 8 years of experience in medical device, healthcare, life sciences, or another regulated industry is required.
Demonstrated experience leading complaint trending, surveillance analytics, quality data analysis, or signal detection processes is required.
Experience establishing or improving statistical methodologies, surveillance systems, or quality analytics programs is required.
Advanced knowledge of statistical process monitoring, signal detection, trend analysis, and surveillance methodologies, including standard-deviation-based criteria and sampling per ANSI/ASQ Z1.4, is required.
Demonstrated experience developing, challenging, and improving trending methodologies rather than solely executing established analyses is required.
A strong understanding of complaint handling, post-market surveillance, CAPA, risk management, and regulatory requirements, including 21 CFR 820, 21 CFR 803, EU MDR Article 85, and UK Post-Market Surveillance Requirements, is required.
Strong proficiency with statistical analysis, exploratory data analysis, data visualization, and business intelligence tools is required.
The ability to identify quality system gaps, establish improvement roadmaps, and lead implementation of sustainable solutions is required.
The ability to evaluate complex quality system issues and develop practical, risk-based solutions balancing compliance, patient safety, product quality, and business objectives is required.
Strong facilitation, communication, and influencing skills, including the ability to communicate complex data clearly across all levels of leadership without direct authority, are required.
Strong technical writing and documentation skills are required.
The ability to provide organizational leadership and strategic direction without formal supervisory responsibility is required.

Responsibilities

Serve as process owner and subject matter expert for BSHS post-market quality complaint trending and related product surveillance review activities.
Establish the strategic direction, governance framework, methodologies, and performance measures for post-market surveillance trending.
Lead 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.
Partner with cross-functional stakeholders to ensure trending outputs are incorporated into quality system processes, including risk management, CAPA, regulatory reporting, management review, field actions, and product improvement activities.
Own the statistical methodologies, normalization approaches, signal detection criteria, escalation thresholds, and decision rules used to identify adverse trends and emerging product quality signals.
Develop, validate, and continuously improve scientifically sound and statistically defensible approaches for complaint trending and signal evaluation.
Evaluate and implement enhanced surveillance approaches, including alert limits, alarm limits, leading indicators, predictive monitoring, and other proactive signal detection methodologies.
Assess the effectiveness of existing trending rules and analytics capabilities to improve sensitivity, specificity, and timeliness of signal detection.
Serve as the organization's subject matter expert for complaint trending methodology, statistical analysis, and signal detection.
Own identification, prioritization, and closure of gaps in complaint trending processes, methodologies, governance mechanisms, systems, and analytics capabilities.
Lead development and execution of improvement roadmaps that strengthen signal detection effectiveness, advance program maturity, and improve overall surveillance capabilities.
Own trending-related remediation activities, including root cause analysis, implementation of corrective actions, verification of effectiveness, and long-term sustainability.
Develop reporting, analytics, and business intelligence solutions that improve visibility into product performance, surveillance effectiveness, and emerging risks.
Provide technical leadership, mentoring, training, and consultation on trending methodologies, signal evaluation, surveillance governance, and post-market analytics while supporting audits, inspections, and management reviews.

Desired Qualifications

Experience supporting CAPA, quality remediation, process improvement, or quality system transformation initiatives is strongly preferred.
Experience with Power BI, SQL, Minitab, Tableau, or similar analytical tools is strongly preferred.

The Lead Post Market Surveillance Specialist serves as the process owner and subject matter expert for BSHS's complaint trending, including methodology, signal detection, surveillance governance, post-market analytics, and associated review and escalation activities.

This role establishes the strategic direction, methodologies, and standards that govern how BSHS identifies, evaluates, and responds to emerging product quality signals. The Lead Specialist is responsible for continuously assessing the effectiveness of the overall trending system, identifying opportunities for improvement, and driving implementation of enhanced surveillance capabilities that enable earlier and more effective detection of product quality risks.

The position also serves as the accountable owner for trending-related quality remediation activities, translating identified process gaps into sustainable improvements through partnership with Product Quality Engineering, Design Assurance, Regulatory Affairs, Corporate Quality, and other quality system stakeholders.

As a lead-level individual contributor, this role provides technical leadership, influences organizational direction, may mentor less experienced personnel, and drives cross-functional alignment.

Essential Duties and Responsibilities:

Trending Strategy, Governance & Process Ownership

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.

Statistical Methodology & Signal Management

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.

Trending Process Improvements and Remediation

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.

Qualifications:

Education

Bachelor's degree required in Engineering, Statistics, Mathematics, Data Analytics, Quality, Life Sciences, or a related technical discipline.

Experience

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.

Skills

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.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

If you have the right skills and experience, apply today!

#LI-AV1

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

About the Company

Hologic

Develops medical devices for early detection

Hologic develops medical devices and diagnostic products for breast health, skeletal health, diagnostics, GYN surgery, and medical aesthetics. Its tests and imaging devices help hospitals and labs screen, diagnose, and guide treatment, while surgical and aesthetic tools support procedures. Revenue comes from product sales and related services. The company aims to improve health by enabling early detection and effective treatment worldwide.

Company size: 5,001-10,000
Company stage: IPO
Headquarters: Santa Clara, CA
Founded: 1985

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