Clinical QA Specialist

Hologic•Newark, DE

10h

About The Position

Are you passionate about ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking a Clinical QA Specialist to play a critical role in the investigation and reporting of potential and actual adverse events, as well as other regulatory reporting activities. In this role, you’ll collaborate with cross-functional teams, including Technical Service, Marketing, Sales, and Regulatory, to ensure timely and thorough documentation, analysis, and reporting. If you thrive in a fast-paced, collaborative environment and have a strong background in regulatory compliance and quality assurance, this is your opportunity to make a meaningful impact on healthcare innovation.

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

Investigate and report potential and actual adverse events.
Perform other regulatory reporting activities.
Collaborate with cross-functional teams (Technical Service, Marketing, Sales, Regulatory) to ensure timely and thorough documentation, analysis, and reporting.
Collect, analyze, and assess information associated with adverse events and determine appropriate next steps.
Support and lead investigations, including CAPAs, nonconformances, and other quality system processes.
Develop metrics and quality reports related to reportable events and identify potential excursions.
Innovate and improve processes to enhance efficiency and compliance with post-market surveillance requirements.
Lead or participate in internal and external audits, inspections, and assessments.