Job Description

Hologic is seeking a Senior Quality Systems Specialist to strengthen and sustain our Quality Management System (QMS) and quality operations. In this role, you’ll work across engineering, supply chain, regulatory, marketing, and other functions to investigate process, product, and system issues, support audits and inspections, and help develop and refine quality procedures. You’ll use data-driven tools to analyze trends, support continuous improvement, and ensure our systems are audit-ready. If you enjoy solving diverse quality challenges, partnering cross-functionally, and owning impactful quality system initiatives in a regulated environment, this role is a strong fit.

Knowledge

  • Working understanding of Quality Management Systems (QMS), especially Management Review, Quality System audits, CAPA, nonconformances, and quality planning.
  • Knowledge and experience with ISO 13485, MDSAP, EU MDR, and 21 CFR 820/QMSR in a medical device or IVD environment.
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