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Regulatory & Quality Assurance
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Thanks for your interest in the Quality Engineer 2 position. Unfortunately this position has been closed but you can search our 203 open jobs by clicking here.
Qualifications:
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.
  • Experience with process, method, facility and/or equipment validation is preferred.
  • Experience with change control systems.
  • Experience with electronic document management systems.
  • Understanding of basic statistics and acceptance sampling.
  • Experience with PFMEAs is preferred.
  • Knowledge of CDRH, CBER and ISO regulations.
  • Knowledge of 21 CFR Part 11.
 
Education:
  • Bachelor’s degree in Engineering
 
Experience:
  • Two years of experience in a diagnostic, medical device, biotech or pharmaceutical company.
 
Physical Demands
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 
  • Sit; use hands to finger, handle or feel objects, tools, or controls.
  • Exposure to moving mechanical parts, vibration and/or moderate noise levels.
  • Exposure to hazardous chemicals or other materials.
  • Exposure to blood.
 
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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