Clinical QA Specialist

Hologic, Inc.; Newark, Northern (DE, KY); Hybrid; USD 85,000 - 133,000; Full time

Job summary

Hologic, Inc. seeks a Clinical QA Specialist to lead investigation and reporting of adverse events and regulatory submissions, collaborating with cross-functional teams to ensure timely documentation and compliant outcomes.

You'll apply knowledge of FDA QSR, ISO 13485, EU MDR, and ISO 14971 to drive risk assessments, CAPA activities, and post-market surveillance across the product portfolio. This role emphasizes proactive problem solving, strong communication with regulatory agencies, and a

Qualifications

• Bachelor's degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering, or related field.
• 5+ years of experience in a similar clinical QA/regulatory role.
• Hands-on experience with adverse event reporting and regulatory communications.
• Proven record in supporting or leading CAPAs and quality investigations.

Responsibilities

• Investigate and report adverse events and other regulatory submissions.
• Collaborate with Technical Service, Marketing, Sales, and Regulatory teams.
• Analyze information, lead investigations, and drive CAPAs and nonconformances.
• Develop metrics and quality reports related to reportable events and excursions.

Skills

Adverse event analysis

Regulatory communications

CAPA investigations

Post-market surveillance

Documentation accuracy

Cross-functional collaboration

Proactive problem solving

Education

Bachelor's degree in Medicine

Bachelor's degree in Nursing

Biomedical/Electromedical Eng.

Related field

Job description

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.

Knowledge:

• 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.

Skills:

• 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.

Behaviors:

• 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.

Experience:

• 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.

Why join Hologic?

We are committed to making Hologic the destination for top talent. 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.

The annualized base salary range for this role is $85,200 - $133,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

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.

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