Quality Assurance Specialist 3

Hologic • San Diego, CA

2d

About The Position

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.

Requirements

• 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.
• 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
• 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.
• 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.
• Bachelor’s 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.
• Completion of on-the-job training including HIPAA and safety procedures.

Nice To Haves

• Experience with MediaLab and medical device quality system regulations is a plus.
• High proficiency in Microsoft Suite; experience with MediaLab preferred.
• ASQ Certification or equivalent experience preferred.
• Experience in medical device quality system regulations is a plus.

Responsibilities

• Drive quality initiatives
• Maintain robust Quality Management Systems (QMS) that meet state, federal, and accrediting body requirements

Benefits

• comprehensive training when you join as well as continued development and training throughout your career

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees