Quality Assurance Specialist 3

As a Quality Assurance Specialist 3 within our Regulatory and Quality - Diagnostics team, you will be integral to ensuring the highest standards of compliance and operational excellence in our laboratory environment. Reporting to the Senior Manager Quality Assurance, you will drive quality initiatives and maintain robust Quality Management Systems (QMS) that meet state, federal, and accrediting body requirements-including California CLIA, CAP, and NYSDOH.

Knowledge

• In-depth understanding of Quality Management System (QMS) requirements and regulatory frameworks such as CLIA, CAP, NYSDOH, and state/federal regulations.
• Advanced knowledge of managing deviations, non-conformances, complaints, and Corrective and Preventive Actions (CAPA).
• Familiarity with Laboratory Developed Tests (LDTs) in CAP-accredited and CLIA-certified environments.
• Working knowledge of risk assessments, compliance audits, and quality improvement processes.
• Experience with MediaLab and medical device quality system regulations is a plus.

Skills

• Demonstrated ability to develop, implement, and enhance QMS for ongoing compliance with regulatory standards.
• Proficient in administering quality programs such as audit, CAPA, change control, document control, and complaints management.
• Skilled in processing complex quality records and higher-level CAPA records with minimal supervision.
• Competence in reviewing validation records, equipment documentation, MLR, materials, and change control documents for accuracy and compliance.
• Strong analytical skills to trend, maintain, and report department metrics and drive process improvement initiatives.
• Ability to lead and provide training on quality processes and procedures.
• Excellent verbal and written communication and presentation skills.
• High proficiency in Microsoft Suite; experience with MediaLab preferred.
• Strong organizational skills, attention to detail, multitasking, and time management in a fast-paced environment.
• Self-motivated, able to work independently and as a cross-functional team member.

Behaviors

• Champion a proactive quality culture through effective training, communication, and ongoing quality awareness.
• Serve as a role model for ethical conduct, adhering to company policies, the Code of Business Conduct, and all applicable regulations.
• Proactive in identifying opportunities for process improvement and executing improvement projects.
• Highly detail-oriented, accountable, and committed to error-free performance.
• Collaborative and communicative, facilitating adherence to quality requirements and supporting cross-departmental initiatives.

Experience & Education

• Bachelors degree in life sciences, physical sciences, engineering, or other technical field required.
• 5-8 years of experience in Quality Assurance Systems.
• Experience investigating and resolving nonconforming events, deviations, and complaints.
• ASQ Certification or equivalent experience preferred.
• Experience in medical device quality system regulations is a plus.
• Completion of on-the-job training including HIPAA and safety procedures.

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 $86,400 - $135,100 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. LI-NT1