Hologic, Inc. · 1 month ago
Clinical QA Specialist
Newark, DE, United States
Full-time
Onsite
Mid, Senior Level
$83K/yr - $130K/yr
5+ years expHologic, Inc. is seeking a Clinical QA Specialist to ensure compliance and patient safety in the medical device industry. The role involves investigating and reporting adverse events while collaborating with various teams to maintain regulatory compliance and quality assurance.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Collaborate with cross-functional teams to ensure timely and thorough documentation, analysis, and reporting of adverse events
Investigate and report potential and actual adverse events and other regulatory reporting activities
Ensure compliance with FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management
Collect, analyze, and assess information associated with adverse events and determine appropriate next steps
Develop metrics and quality reports related to reportable events and identify potential excursions
Lead or participate in internal and external audits, inspections, and assessments
Qualification
Required
Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management
Strong knowledge of medical procedures and the expected and potential outcomes related to Hologic's product portfolio
Familiarity with post-market surveillance requirements, adverse event reporting, and health risk assessments
Awareness of regulatory reporting processes, including MedWatch reports, notified body communications, and external notifications
Proven ability to independently collect, analyze, and assess information associated with adverse events and determine appropriate next steps
Effective communication skills to interact with internal teams, sales personnel, customers, patients, and regulatory agencies
Strong organizational skills to ensure timely documentation, reporting, and follow-up of adverse events and regulatory submissions
Analytical skills to support and lead investigations, including CAPAs, nonconformances, and other quality system processes
Experience in developing metrics and quality reports related to reportable events and identifying potential excursions
Ability to innovate and improve processes to enhance efficiency and compliance with post-market surveillance requirements
Proficient in leading or participating in internal and external audits, inspections, and assessments
Proactive and detail-oriented, ensuring compliance with regulatory requirements and internal procedures
Collaborative and team-oriented, fostering strong relationships across functions to support investigations and reporting activities
Customer-focused, ensuring communications and responses are timely, accurate, and aligned with patient safety goals
Resilient and adaptable, thriving in a fast-paced and evolving environment
Problem-solving mindset, with a commitment to driving resolution and continuous improvement in quality processes
Bachelor's degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering, or a related field. Risk Managers will also be considered
5+ years of experience in a similar role, preferably within the medical device or healthcare industry
Hands-on experience with adverse event reporting, regulatory communications, and health risk assessments
Proven track record in supporting or leading CAPAs, nonconformances, and quality investigations
Benefits
Comprehensive training
Continued development and training
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-17
Company data provided by crunchbase