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Senior Quality Assurance Specialist, Nonconformance and CAPA


PayCompetitive
LocationChicago/Illinois
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: 7295736002
      Employer Industry: Healthcare Technology

      Why consider this job opportunity:
      - Competitive salary up to $X
      - Opportunities for career advancement and growth within the organization
      - Supportive and collaborative work environment
      - Chance to work with cutting-edge AI technology in healthcare
      - Positive impact on patient care and treatment outcomes

      What to Expect (Job Responsibilities):
      - Manage incidents, deviations, nonconformances, and corrective and preventive actions in compliance with FDA QSR, ISO 13485, and other global regulations
      - Collaborate with Regulatory on health authority reporting
      - Conduct investigations, root cause analysis, and closure of NC/CAPA activities
      - Provide training and guidance to issue owners for resolution and closure
      - Drive root cause analysis and corrective actions to prevent quality issue recurrence

      What is Required (Qualifications):
      - Bachelor's Degree in Engineering or Science field
      - 3+ years of QA experience in a clinical laboratory/medical device/Diagnostic company
      - Working knowledge of medical device/in vitro diagnostic regulations
      - Strong communication, influencing, negotiating, and collaboration skills
      - Ability to manage multiple tasks with limited supervision

      How to Stand Out (Preferred Qualifications):
      - Experience in a clinical molecular testing laboratory
      - Familiarity with deviations, NC, and CAPA processes

      #HealthcareTechnology #QA #CareerOpportunity #CompetitivePay #QualityAssurance

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      We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
  • About the company

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