Clinical QA Specialist

Hologic; Town of Newark (WI); On-site; USD 85,000 - 133,000; Full time

Job summary

Hologic, Inc. is seeking a Clinical QA Specialist to support adverse event investigations, regulatory reporting, and post‑market surveillance in a fast‑paced medical device environment.

You will collaborate with Technical Service, Regulatory, Marketing, and Sales to ensure timely, thorough documentation and compliant submissions, leveraging knowledge of FDA QSR, ISO 13485, EU MDR, and risk management to protect patient safety.

Qualifications

• Bachelor’s degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering, or related field.
• 5+ years in a similar clinical QA or regulatory role in medical devices.
• Hands-on experience with adverse event reporting and CAPA investigations.
• Proven track record in regulatory communications and health risk assessments.
• Auditing and inspection experience preferred.

Responsibilities

• Investigate adverse events and determine appropriate regulatory actions.
• Prepare and submit regulatory reports and health risk assessments.
• Lead or support CAPAs, nonconformances, and quality investigations.
• Collaborate cross-functionally with Technical Service, Marketing, Sales, and Regulatory.

Skills

Adverse event investigation

Regulatory reporting

CAPA management

Cross-functional collaboration

Documentation and data analysis

Education

Bachelor’s degree in Medicine, Nursing, Biomedical 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 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.

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

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