Quality Specialist - Product Complaints

Hologic•San Diego, CA

14h•$71,000 - $104,600

About The Position

The Post-Market QA Specialist plays a key role in ensuring the safety, effectiveness, and regulatory compliance of Hologic’s on-market molecular diagnostic products. The ideal candidate will be responsible for monitoring and facilitating the handling of post-market complaints as well as ensuring compliance with applicable industry regulations, standards, and company policy. The role may support product complaint investigations, including lab testing, risk assessment and root cause analysis across Hologic’s global molecular diagnostic product lines.

Requirements

B.S. in scientific or engineering discipline.
3+ years of experience in a quality role within an ISO 13485 quality management system, ideally with focus on Post-Market Surveillance, complaint handling, and / or complaint trending.
Working knowledge of post-market surveillance, complaint handling, risk management, and non-conformance / CAPA processes.
Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and global post-market surveillance requirements.
Basic knowledge of tracking and trending product / process metrics and KPI’s with statistical methods and data visualization tools (e.g., Power BI), ideally for manufacturing or technical support of high volume products.
Aptitude to clearly explain data, processes, compliance requirements to cross-functional audiences in meetings, presentations, and reports.
Skilled at planning, executing, and managing tasks and processes to drive action individually and with others in a team setting.
Aptitude to compile, research, and critically evaluate data to identify and understand patterns / trends as well as make informed conclusions.
Detail Oriented: proactively identifies and focuses on critical details needed to ensure accurate and high-quality results.
Inquisitive: strong intellectual desire to understand and address technical issues by seeking information through asking probing questions, research, data analysis, and collaboration with others.
Quality / Safety Focused: committed to ensuring product quality and safety by making and documenting objective conclusions based on data and facts.
Resourceful: applies self-directed research, problem solving, critical thinking, collaboration skills to approach uncertainty and adapt to change.

Nice To Haves

Prior experience supporting development and / or manufacturing of IVD or other medical device products preferred.
Familiarity with processes and practices related to the design and manufacturing of in vitro diagnostic or medical device products, ideally with high volume automated reagent / hardware systems.

Responsibilities

Receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR).
Conduct initial assessments of complaints and work with cross-functional teams as needed to support timely investigation, root cause analysis, and resolution of complaints of moderate complexity.
Ensure timely, accurate, and complete complaint records in the complaint management system.
May support product complaint investigations, including lab testing, risk assessment, and root cause analysis as needed.
Identify and escalate potential adverse events to QA management.
Support preparation and submission of regulatory reports (e.g., FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements.
Ensure post-market activities are compliant with Hologic’s quality system and all applicable standards.
Sustain routine monitoring and trending of product performance, complaint data, adverse event reporting data, and quality KPI’s to identify and track potential product issues.
Support internal and external audits related to post-market surveillance and complaint handling as needed.
Maintain accurate and audit-ready documentation.
Contribute to the development and improvement of processes, SOPs, work instructions, and training materials related to post-market quality assurance.
Train others as needed.