Hologic, Inc.

QA Specialist

Hologic, Inc.  •  Tokyo, JP (Onsite)  •  2 hours ago
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Job Description

  • 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.
Hologic, Inc.

About Hologic, Inc.

We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While we discover and develop groundbreaking products and services that benefit everyone, we are especially passionate about those that advance women’s health and well-being. This allows us to be a company that prospers, grows and empowers women to experience healthier lives.

None of this would be possible without the talent, skills and aspirations of our employees. Their expertise and dedication to developing and sharing more robust, science-based certainty drives our increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families and communities.

What powers our growth across Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates us: the exceptional and clinically proven ability of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by always challenging ourselves to improve health through better technology, education and market access. Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.

We work toward this goal every day, always aware that in an increasingly complex and competitive global environment, we must continually earn the trust of our customers and their patients. By focusing on women’s health while still delivering health benefits to everyone, we are setting a new standard of excellence that is strengthened by purpose, driven by passion and brought to life by our promise of more certain early detection and better health outcomes.

To view our community guidelines, visit: www.hologic.com/social-media

Industry
Manufacturing & Production
Company Size
5,001-10,000 employees
Headquarters
Marlborough, MA
Year Founded
1985
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