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Senior Quality Assurance Engineer

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Regulatory & Quality Assurance
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1932 Total Views
Thanks for your interest in the Senior Quality Assurance Engineer position. Unfortunately this position has been closed but you can search our 188 open jobs by clicking here.
Qualifications
Education          
  • B.S. degree in related discipline
  • Education/training in developing and maintaining compliant Quality Systems
 
Experience         
  • 5 years of experience developing, managing, executing, and improving Quality Management Systems in the medical device/pharmaceutical industry
  • Strong working knowledge of domestic and international regulations for medical device manufacturing and distribution
 
Skills
  • Strong knowledge of the regulation associated with the domestic manufacturing and distribution of medical devices (ISO 13485, 21 CFR 820, etc.)
  • Experience with the design, development, and implementation of compliant QMS documents (Standard Operation Procedures, Work Instructions, Forms, etc.)
  • Experience with the managing and execution of CAPAs and the CAPA system
  • Experienced with the administration of the Supplier Management process (qualification, control, audit scheduling, etc.)
  • Experience with managing and executing internal audits
  • Experience with trending, analyzing, and reporting Quality data
  • Working knowledge of MDD 93/42/EEC (EU), TGA 2002 (Australia), BGMP RDC 16 (Brazil), CMDR SOR-98-282 (Canada), MHLW Ministerial Ordinance No. 169 (Japan), etc.
  • Certified Lead/internal auditor to ISO 13485.
  • Experience managing, executing, and improving processes defined in the Quality Management System (Internal Audit, Supplier Management, CAPA, etc.)
  • Experience using Agile or equivalent
  • Experience with the use of common software and analysis tools (MS Word, Excel, Minitab, etc.)
  • Detail-oriented and collaborative mindset

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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