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 requirementsincluding California CLIA CAP and NYSDOH.

• 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.

• 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.

• 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.

• Bachelors degree in life sciences physical sciences engineering or other technical field required.
• 58 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 $86400-$135100 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 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.

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