QA Specialist, Post Market Quality Assurance

Hologic • San Diego, CA

20h • $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 medical devices after release. The
ideal candidate will be responsible for monitoring and facilitating post-market
complaints, 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 as needed.
Success in this role requires strong analytical skills, attention to detail, and
effective collaboration with cross-functional teams to resolve issues of
moderate complexity and drive continuous improvement.

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

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Quality, CQE certification is preferred.
• 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.
• 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
• Experience with risk management, CAPA, or audit support.
• Working knowledge of post-market surveillance, complaint handling, risk management, Non-conformance and global regulatory reporting requirements (e.g., FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR).
• Working Knowledge of statistics or data visualization tools.
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.
• Strong organizational and documentation skills.
• Ability to work independently and collaboratively in a cross-functional environment.
• Detail-Oriented: Proactively identifies and focuses on critical details needed to ensure accurate documentation and investigation.
• Inquisitive: Strong intellectual desire to understand and address issues by seeking information 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.

Responsibilities

• Complaint Handling and Investigation: 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.
• Regulatory Reporting: 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
• Data Analysis & Trending: 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
• Audit & Inspection Support: Support internal and external audits related to post-market surveillance and complaint handling as needed. Maintain accurate and audit-ready documentation.
• Training & Process Development: Contribute to the development and improvement of processes, SOPs, work instructions, and training materials related to post-market quality assurance Train others as needed.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level