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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.
  • Demonstrated experience in the effective application and meeting requirements of FDA 21 CFR Part 820 QS regulations and ISO 13485/ 14971 standards, as well as CE regulations.
  • Strong influencing and negotiation skills
  • Experience with quality and process improvement methodologies and tools Knowledge of  validation methods & evaluation criteria
  • Advanced knowledge of design control, change control, QC, manufacturing & inventory
  • Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES).
  • Experience with enterprise Quality System tools (e.g., electronic CAPA, Complaint Management systems)
  • Working knowledge of statistical principals of DOE, ANOVA, Cpk, etc.
  • Understanding of engineering drawings and symbols
  • Good knowledge of sampling plans
 
 
Education:
  • BS or equivalent in an engineering or life science discipline.
Experience:
  • Typically with 5- 7 years of related experience.
  • Experience working in a regulated environment,  in-vitro diagnostics preferred
  • Quality Certification preferred (e.g., CQE, CQA, SQE, 6-Sigma, Lean)
  • Advanced knowledge of scientific principles and concepts.
 
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