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Quality Assurance Inspector Lead - (1st Shift)

Company: GenMark Diagnostics, Inc.
Location: Carlsbad
Posted on: April 9, 2021

Job Description:

Quality Assurance Inspector Lead - (1st Shift) Do you want to join a company where you can be a hero too? We deliver innovative, diagnostic solutions that improve the lives of patients and their families and are proud to be one of the heroic diagnostic companies that is in this fight against COVID-19. As a member of GenMark's team, you'll get to be part of an organization where we embody our cultural beliefs in everything we do. The following is a glimpse of what our culture looks like and If you'd like to join us, we encourage you to apply as our company is growing!

  • Go Big - We never settle and challenge what's possible
  • Win Together - We are one team with a shared purpose
  • Own It - We step up, drive it, and deliver it
  • Be Bold - We empower ourselves and others WHAT YOU WILL DO AT GENMARK-- This position is responsible to perform inspections and measurements for raw material parts and in-process involving prescribed measurement tools. This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols. Demonstrate leadership abilities in the absence of the Supervisor. This position interfaces with engineering, manufacturing and others as necessary regarding inspection quality related issues.
    • Responsible for day-to-day supervision and coaching of assigned shift to achieve daily, weekly and monthly receiving inspection metrics/goals.
    • Strategically prioritize inspections and resources to accommodate Manufacturing's needs in the absence of direct QA Supervisor.
    • Generate daily schedule for incoming inspection of materials for the QAI Group.
    • Provide/present QAI metrics to Quality Management on a monthly basis or upon QA Supervisor's request.
    • Perform QAD transactions of materials to release inventory.
    • Collaborates with engineering to update inspection work instructions and/or material specification sheets.
    • Ensures calibration and maintenance is performed in inspection equipment.
    • Maintain inspection related NCRs for appropriate disposition.
    • Act as liaison with warehouse as necessary to resolve incoming material issues.
    • Collaborate with Warehouse to resolve incoming paperwork discrepancies.
    • Performs troubleshooting and makes recommendations, as necessary. Uses technical knowledge to develop new solutions for routine and non-routine technical problems.
    • Uses judgement and problem-solving skills to provide input in measurement equipment, systems and processes.
    • Ensure new hires are properly trained on all inspection procedures, including safety and quality. In addition will motivate inspectors.
    • Interacts professionally with other departments to provide detailed data, analysis results of inspection activities.
    • Work closely with the Quality Engineering and purchasing to improve the product/test capability and receiving inspection process, while striving to improve quality and reduce cost through communication and problem solving, tracking nonconformance causes and participating in work area meetings.
    • Updates inspection logs and reviews batch records for completeness and GDP standards. Education and Experience--
      • Minimum HS diploma and two plus (2+) years' experience; Associate's degree in a technical field or other technical degree is preferred.
      • Demonstrated leadership abilities in a QA function.
      • Experience using eQMS and/or ERP software preferred.
      • Familiar with AQL Sampling, reduced inspections, tightened inspections and switching rules.
      • Possesses the ability to read and interpret component drawings and use measurement tools such as caliper.
      • Possesses the ability to evaluate certificate of analysis of chemicals /raw materials.
      • Uses measuring tools, measuring machines, and electronic instruments to perform inspections in accordance with authorized specification and quality control standards.
      • Understanding of ANSI.ASQ Z1.4 sampling plans.
      • The ideal candidate will be highly motivated and work well in a leadership position in a team environment.
      • Experience working in an FDA regulated environment is preferable. ABOUT GENMARK GenMark's ePlex true sample-to-answer system symbolizes the evolution of eSensor technology combined with digital microfluidics. ePlex offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report, and is the only true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California

Keywords: GenMark Diagnostics, Inc., San Diego , Quality Assurance Inspector Lead - (1st Shift), Other , Carlsbad, California

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