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Regulatory & Quality Assurance
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Thanks for your interest in the Sr. Quality Engineer position. Unfortunately this position has been closed but you can search our 276 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.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

  • Must be computer literate: Microsoft Word, PowerPoint, Outlook and Excel.
  • Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
  • Excellent written, verbal and presentation skills.
  • Excellent interpersonal skills to interact with all levels of the company and oversight agencies, sometimes in an adversary role.

Education

  • Bachelor’s degree or equivalent combination of education and experience
  • Experience
  • Five to ten years related experience in an FDA regulated industry with at least three years recent experience in Medical Devices or equivalent combination of education and experience.

Specialized Knowledge

  • Excellent working knowledge of medical device regulations (21CFR, ISO13485, MDSAP and MDR/IVDR).
  • Certified Quality Engineer and/or Certified Lead Auditor.
  • Familiarity with the corrective action and internal audit processes related to the medical device industry

Additional Details  

  • Must be able to use hands and be mobile to get around production floor, engineering labs, warehouse and dock areas.
  • Vision abilities required include:  close vision, distance vision, color vision, depth perception and ability to adjust focus
  • Must be able to work independently and make decisions based on data and objective evidences.

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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