Sr. Quality Engineer Job Summary: Contract :12 months duration Location: Deerfield, IL * Must be able to work Hybrid 2-3 days/week for first 4-6 months minimum. In this Quality Engineering position,">

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Sr. Quality Engineer

Company: Automated Systems, Inc.
Location: Deerfield
Posted on: September 18, 2022

Job Description:

"> Sr. Quality Engineer Job Summary: Contract :12 months duration Location: Deerfield, IL * Must be able to work Hybrid 2-3 days/week for first 4-6 months minimum. In this Quality Engineering position, the incumbent should display a basic understanding of the Product Engineering and Quality Management System concepts. - The individual will be responsible to help update DHF and technical files to be EU MDR compliant and meet all Design Control and Risk Management requirements by following applicable safety, quality, regulatory procedures and processes to develop safe medical device. - Works with Cross-Functional teams effectively to support EU MDR product certification submissions. - Provides Quality compliance input to the project team for project deliverables (e.g. Product Specifications, Risk Files, Design Reviews, V&V, Design Transfer, Clinical Evaluation Plans/Reports, etc..) and demonstrating commitment to patient safety and product quality. - Perform document reviews as Quality Reviewer to support EU MDR project activities such as design and labeling change controls. - Utilizes engineering and quality tools/methodologies (e.g. Six Sigma-DMADV DMAIC,---) to investigate complex and diverse product technical product problems and develop solutions which require critical, analytical, and creative thinking. - Familiarity with Medical Device Directive (MDD)/Medical Device Regulation(MDR) requirements for design control and product risk management. Education and Experience:

  • BS in Engineering with preference in Mechanical, Biomedical, or Chemical Engineering.
  • One to three years of Quality experience with preference in medical device industry.
  • Strong communication skills (verbal and written) and team player.
  • Understanding and working experience with medical device industry quality requirements associated with product development, design control, and product risk management.
  • Understanding and working knowledge of FDA regulation 21 CFR Part 820 and international regulations EN ISO13485 and EN ISO 14971 Job Requirements:
    • Creating test schedules, detailing test cases
    • Develop and execute test plans and test cases
    • Develop an automation test strategy to covert manual test scenarios/test cases into scripts
    • Develop and document test plans and test specifications
    • Creating test plans, test procedures and test scripts in support of the formal testing process
    • Perform functional black and white box testing and test automation
    • Provide test reports upon completion of testing
    • Assist in writing and executing manual test plans and related test cases
    • Develop and maintain comprehensive test plans and test cases to verify functionality
    • Create and maintain software test cases exercising both positive and negative test paths
    • Write test plans and test cases for all NMS components
    • Create detailed, comprehensive, and well-structured test plans and test cases
    • Develop reusable test plan, test specification, and test case templates and processes
    • Integrating test automation with the build process
    • Execute test cases and logs/retests issues
    • Develop and execute test strategy and detailed test plans for major software development initiatives
    • Review use cases and develop and execute test plans, test specifications, and test cases to ensure application development meets business requirements
    • Work closely with test manager, test methodologists, and test lead to formulate and implement the testing framework
    • Develop and document test cases
    • Develop risk based test plans that incorporate defect prevention practices, unit testing, test-driven development and use testing strategies to assure quality software products

Keywords: Automated Systems, Inc., Arlington Heights , Sr. Quality Engineer, Engineering , Deerfield, Illinois

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