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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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