Post Market Quality Specialist 2

Hologic • Newark, DE • 4h ago

Newark, DE, United States

The Post Market Quality Specialist performs statistical analysis of complaint and post market data for assigned Hologic product families, identifying trends, emerging signals, and opportunities for quality improvement. The Specialist owns and leads the Post Market Surveillance Review Boards (PMS RBs), presenting product performance metrics, trend summaries, and identified signals requiring follow up.

Working in close partnership with Product Quality Engineers (PQEs), the Specialist supports moderate complaint investigations by providing high quality data analysis, code review, and early signal assessment to inform cross functional decisions. The role maintains and reconciles PMS datasets, contributes complaint data for required PMS documentation, and serves as the primary point of contact for complaint related analytics.

Essential Duties and Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Complaint & Post Market Data Analysis

Perform routine and ad hoc analysis of complaint and post market data for assigned product families

Identify trends, anomalies, and early warning signals using statistical methods and established KPIs

Extract and validate complaint data to support PQEs, QDEs, and cross functional investigation teams.

Conduct "as reported vs. as analyzed" complaint code reconciliation to ensure accurate surveillance insights.

PMS Review Boards (PMSRBs)

Own, schedule, prepare, and present BU level Post Market Surveillance Review Boards

Summarize key complaint trends, signals, KPIs, and actions required for follow up

Ensure PMS RB records are accurately documented and released in PLM in a timely manner

Investigation Support

Support product investigations in partnership with PQEs and QDEs, providing data analysis, trending support, and preliminary signal assessment.

Provide rapid complaint data inputs for emerging issues, field escalations, and early investigations

Perform queries and generate trend analyses for CAPA inputs, Health Risk Assessments (HRAs), and cross functional assessments

PMS Documentation & Reporting

Supply complaint data for PMS Plans, PMS Reports, PSURs, and Canadian Summary Reports, as requested

Provide complaint data to support PMCF and Clinical Evaluation documentation

Maintain surveillance trackers, templates, and other PMS documentation tools to ensure accuracy, consistency, and compliance

Compile and report weekly and monthly surveillance metrics and KPIs to support Quality leadership

Cross Functional Collaboration

Partner closely with PQEs, Product Support, QDEs, and other key functions to ensure consistent complaint coding, accurate data interpretation, and alignment on findings

Support cross functional discussions on product performance, emerging risks, and needed follow up actions

Continuous Improvement & Data Quality

Recommend and implement improvements to complaint coding, data quality, PMS processes, and analytical workflows.

Support alignment of divisional PMS processes with corporate standards and data governance expectations.

Contribute to internal and external audits/inspections by providing accurate complaint data and documentation support.

Qualifications:

Education

Bachelor's degree in Engineering, Science, or related technical field

Experience

3+ years in post market quality, complaint handling, quality engineering, or similar analytical role. Medical device experience preferred

Skills

Strong analytical and statistical skills; experience identifying trends and early warning signals

Working knowledge of FDA 21 CFR 820.198, ISO 13485, ISO 14971, and EU MDR PMS requirements

Strong communication skills for presenting data to cross functional teams and leadership

Effective organization, prioritization, and problem solving skills

Computer skills: Microsoft Office, Minitab, Oracle, Agile and Salesforce (H1)

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.

Hologic

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