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Regulatory & Quality Assurance
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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity 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 continually challenging ourselves to improve health through better technology, education and market access.
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
Job Summary
Quality Inspectors verify incoming and manufactured materials meet established specifications, through defined procedures and processes. Inspectors support and work with Operations and other Quality groups to ensure acceptance activities are met and records are maintained. Inspectors are responsible for ensuring compliance with FDA regulations and ISO requirements. Team and independent work is required, under varying levels of supervision.
Duties & Responsibilities:
  • Inspects raw materials, components, and finished kits.
  • Initiate NCEs
  • Maintains inspection and lab records.
  • Perform laboratory maintenance per written protocols (e.g. cleaning, equipment and maintenance calibration).
  • Ensures completion and implementation of compliance and procedural training.
  • Identifies and performs general process improvements for productivity, quality, or safety.
  • Generate metrics for Quality Inspection.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.
  • Basic knowledge of FDA regulations and ISO requirements
  • General knowledge of basic measurement devices
  • Written and verbal communication skills
  • Basic computer skills
  • Basic math skills
  • Organization skills
High school diploma or GED required
0-2 years’ related work experience required
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 Department. In 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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📁 Regulatory & Quality Assurance