Quality Assurance Analyst (Post-Market Surveillance)

Hologic • San Diego, CA • 6d ago

San Diego, CA, United States

The Quality Assurance Analyst is responsible for creating and maintaining Post Market Surveillance (PMS) activities for Hologic's Diagnostic Solutions Division (Molecular, Cytology, and Perinatal). This role ensures compliance with applicable regulations, including EU IVDR, Great Britain, and Health Canada Summary Reports, for both current and newly introduced products. The analyst will work collaboratively with cross-functional teams to support product safety, regulatory compliance, and continuous improvement.

This is a fully onsite role based out of San Diego, CA.

Key Responsibilities

Create and maintain the Diagnostics and Perinatal global PMS documentation (PMS Reports (PMSR), Periodic Safety Update Reports (PSUR)) for European IVDR, Great Britain, and Health Canada Summary Reports, or any future PMS requirements.

Ensure timely completion and compliance with applicable regulatory requirements.

Collect global PMS data from complaints, CAPAs, sales, reportable events, and trends for each product.

Analyze global post market data for each product including complaint trend analysis, volume of sales and rates, recalls and incident reporting

Assess trends by reason, severity, and lots in the PMS reports.

Assess and submit a trend report for any statistically significant increase in the frequency or severity of non- incidents.

Review recalls, serious incidents, and CAPAs for each product and determine inclusion / exclusion decisions.

Perform public adverse events and recall database searches for subject and similar devices.

Analyze adverse events and recall database search results for applicability to subject and/or similar device for inclusion/exclusion decision.

Evaluate PMS reports by each product for updates to the risk-benefit determination and to determine if any additional activities are required for improving the design, manufacturability, or product labeling.

Summarize collected and analyzed PMS data in a report using technical knowledge and ensuring high quality and compliance of report content.

Submit PMS documentation in agile for approval.

Maintain updates to the PMS procedures and templates as needed.

Maintain an understanding of global medical device regulations in relation to Post Market Surveillance and recognize and implement enhancements as needed.

Maintain a working knowledge of Hologic products this position supports.

Interacts/coordinates with and supports other departments and SMEs as needed.

Communicate results and conclusions from sustaining reports to stakeholders.

Assist in audits and additional QA duties as assigned.

Perform other function-related activities in addition to the above-mentioned responsibilities as reasonably required by business needs.

Required Qualifications and Skills:

Bachelor's degree in Science, Engineering, or a healthcare-related field.

Minimum of 2 - 5 years of experience in post-market surveillance or quality assurance in the medical device industry or related field.

Knowledge of regulations for In-Vitro Diagnostic Regulation (2017/746) and Health Canada regulations is strongly desired.

Excellent technical writing skills, analytical skills, and ability to communicate and present technical information.

Understanding of QSR & ISO requirements.

Prior experience of processing medical device or drug complaints, CAPAs, and reportable events preferred.

Must demonstrate initiative, balanced assertiveness, flexibility and team orientation

The annualized base salary range for this role is $69,000 to $102,300 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-RF1 #mid-level

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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