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Quality Assurance Manager

Quality Assurance Manager

ClinLab StaffingFort Worth, TX, United States
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Job Title / High-Level Position Summary :

The Quality Assurance Manager is responsible for managing, developing, implementing, and maintaining technical systems and activities for a small Quality Assurance and / or Quality Control group.

Key Responsibilities :

  • Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing and evaluating the quality, precision, accuracy and reliability of company products.
  • Ensures compliance with Company standards and government regulations.
  • Participates in the reviewing and assessing of engineering designs.
  • Assists product support areas in gathering and analyzing data.
  • Responsible for monitoring and reporting on product quality, performance and reporting on this through management review.
  • Candidate must have a strong understanding / knowledge of FDA device requirements, ISO 13485, MDSAP and will be required to represent the business in audits of these areas.
  • It is essential that they have a solid understanding of root cause analysis, CAPA and none-conforming product management.
  • Has typically authority of a manager including hiring, disciplining, and terminating.
  • Has budgetary responsibility.

Minimum Qualifications :

  • 8+ Yrs of Work Exp in QA with a specific focus on Medical Devices
  • BS / BA
  • Desired Characteristics :

  • 5+ yrs of mgmt. exp
  • Lean or 6 Sigma Certification

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    Quality Assurance Manager • Fort Worth, TX, United States