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Quality Engineering Manager

Company: Tisora Group
Location: Hoffman Estates
Posted on: January 16, 2022

Job Description:

Medix is seeking a Quality Assurance Engineer for a global leader operating in the health and beauty sector near Hoffman Estates. Serving both the professional and consumer customers worldwide, this individual will be responsible for new product testing, test method development, process and design validations, and quality improvement projects to ensure FDA and ISO compliance.
Responsibilities:

  • Participate in the product development process as required to ensure that customer requirements are met
  • Perform product validation testing, develop test methods, protocols, and issue reports as needed
  • Support the process and product FMEA, and Risk Management activities
  • Monitor and analyze effectiveness of process controls in support of validation maintenance
  • Lead and facilitate CAPA project teams as required to ensure continuous quality improvement
  • Assume the facility customer complaint responsibilities regarding failure analysis, root-cause investigation, and corrective action as required per corporate policy
  • Participate in the development, execution, analysis and reporting of first-article qualification and process validations as required
  • Perform and document equipment and process Capability Studies
  • Conduct analytical testing and root cause analysis for process nonconformance
  • Develop and prepare facility quality performance reports, charts, and graphs as needed for management decision making.
  • Conduct comparative tests on competitive products, issue evaluation reports
  • Lead six sigma projects
  • Provide technical leadership for the quality team
  • Support the internal auditing program
    Requirements:
    • Technical 4-year degree, preferably Bachelor of Science in Engineering
    • Minimum 3 years Quality Control experience in a medical device manufacturing facility
    • Familiarity with quality engineering methods
    • Excellent computer skills. Experience with MS Office applications
    • Knowledge of FDA regulations and ISO 13485 standard
    • Must possess excellent written and verbal communication skills, team facilitation skills, advanced problem-solving skills, and the ability to communicate effectively with all levels within the organization
      Benefits:
      • Comprehensive insurance coverage that includes Medical, Vision, Life and disability insurance plans along with enhanced Dental benefits
      • Wellness program including an onsite fitness center
      • 401K retirement plan with 5% employer match (Pretax and Roth options)
      • 401k profit sharing contribution based on company performance
      • Paid holidays and generous paid time off
      • Competitive annual bonus and sales incentive programsby Jobble

Keywords: Tisora Group, Hoffman Estates , Quality Engineering Manager, Executive , Hoffman Estates, Illinois

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