Job DescriptionAre 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.
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.
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