Clinical QA Specialist

DIRECT SALES, US; Newark (DE); On-site; USD 85,000 - 133,000; Full time

Job summary

Hologic is seeking a Clinical QA Specialist to investigate and report adverse events and manage regulatory reporting activities. The role collaborates with Technical Service, Marketing, Sales, and Regulatory to ensure timely documentation and thorough analysis.

Candidates should have a strong regulatory compliance and quality assurance background in medical devices, with 5+ years of relevant experience. The position offers a competitive base salary and bonus eligibility.

Qualifications

• Bachelor’s degree in a medical/engineering field or related discipline; Risk Managers considered.
• 5+ years in a similar clinical QA/regulatory role in medical devices or healthcare.
• Hands-on adverse event reporting, regulatory communications, and health risk assessments.
• Proven track record in supporting or leading CAPAs, nonconformances, and investigations.

Responsibilities

• Investigate and report potential and actual adverse events.
• Collaborate with cross-functional teams to document, analyze, and report regulatory information.
• Lead or participate in audits, inspections, and quality system activities.

Skills

Adverse event analysis

Communication with regulators

CAPA investigations

Nonconformances handling

Quality investigations

Metrics & reporting

Process improvement

Audit support

Education

Bachelor’s degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering or related field

Job description

Are you passionate about ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking aClinical QA Specialistto 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+ yearsof 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.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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