Senior Quality Assurance Specialist

1 week ago


Northridge, California, United States Entegee Full time
Job SummaryEntegee is seeking a highly skilled Senior Quality Engineer to join our team. As a Senior Quality Engineer, you will be responsible for ensuring quality compliance in class III medical devices, including design controls, process validation, risk management, statistical analysis, and test method validation.Responsibilities
  • Ensure compliance with design controls (21 CFR 820)
  • Perform process validation (IQ, OQ, PQ)
  • Conduct risk management activities
  • Perform statistical analysis using MINITAB
  • Validate test methods for quality assurance
  • Support quality assurance processes for class III medical devices
Requirements
  • Background in class III medical devices
  • Knowledge of Design Controls (21 CFR 820)
  • Experience with Process Validation (IQ, OQ, PQ)
  • Expertise in Risk Management
  • Proficiency in statistical analysis (MINITAB)
  • Experience with Test Method Validation
  • BSEE, ME, or Biomedical degree
Benefits

Entegee offers a competitive salary range of $40.00 to $54.00 per hour, as well as a comprehensive benefits package, including medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan.

Our benefits program provides employees with the flexibility to choose the type of coverage that meets their individual needs. We also offer paid leave, including Paid Sick Leave, as required by law, and Holiday pay upon meeting eligibility criteria.

Entegee is an Equal Opportunity Employer/Veterans/Disabled. We consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

To learn more about our Candidate Privacy Information Statement, please visit https://www.entegee.com/candidate-privacy-information-statement/.



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