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QA Specialist

Hologic • Hospitals & Health Systems • 3 months ago
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Location
In office (Tokyo)

Confirmed on the employer's own hiring board on Oct 5, 2026. First seen by Alion on Jul 27, 2026. Hologic scores B on the Alion truth index.

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Hologic

Hologic is a medical technology company headquartered in Marlborough, Massachusetts, that develops diagnostics, breast and skeletal imaging and surgical products with a focus on women's health. Founded in 1985 and listed on Nasdaq, it makes mammography and breast biopsy systems, molecular diagnostic assays and gynecological surgical devices, with manufacturing in Newark, San Diego and Alajuela in Costa Rica, and it acquired the UK breast surgery firm Endomag. It hires electrical and software engineers, chemists, clinical account managers, field service engineers, manufacturing supervisors, quality specialists and finance analysts.
hologic.com • HQ: Marlborough, United States • Women’s Health & Maternity • Surgical Instruments & Devices • Medical Imaging Systems • Diagnostic Tests & IVD • 1001-5000 employees • Est. 1985
Tech stack of Hologic
Backed by Runway Growth Capital, Kaiser Permanente Ventures, Lightstone Ventures
  • Participate and support internal and/or external audits, inspections, or surveillance to demonstrate compliance with the regulations or standards such as QMS Ordinances No.169, ISO13485, and MDSAP audit requirements.
  • Organize and review processes, Quality Manual, Standard Operation Procedures, Working Instructions, QMS records, and other documents to assure regulatory compliances.
  • Evaluate necessity of action (CAPA, regulatory reporting and/or field action, improvement) from identified non-conformance, non-conformity and complaint. In addition, managing it.
  • Other improvements in QMS and Vigilance processes as MAH to adopt regulatory requirement, corporate polices and environmental change.
  • Participate in cross-functional team for new product introduction to provide expertise in quality and safety of Medical Devices, IVDs, and other products.
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