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Quality Engineer II

Company: Apex Systems
Location: Saint Paul
Posted on: February 23, 2021

Job Description:

Essential Job Duties and Responsibilities

  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Coach and mentor non-exempt personnel
  • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Design and conduct experiments for process optimization and/or improvement
  • Appropriately document experiment plans and results, including protocol writing and reports
  • Lead process control and monitoring of CTQ parameters and specifications
  • Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
  • Lead the investigation, resolution and prevention of product and process nonconformances and customer complaints
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
  • Lead in the completion and maintenance of risk analysis
  • Work with design engineering in the completion of product verification and validation
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.
  • Coach and mentor non-exempt personnel Education and Experience Requirements
    • BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
    • 3+ years' experience
    • ASQ CQE or other certifications preferred
    • Prior medical device experience preferred
    • Engineering experience and demonstrated use of Quality tools/methodologies
    • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
    • Experience participating in Quality System audit preferred
    • Experience working in a broader enterprise/cross-division business unit model preferred. Skills and Abilities
      • Knowledge of FDA, GMP, and ISO 13485
      • Solid communication and interpersonal skills
      • Advanced computer skills, including statistical/data analysis and report writing skills EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice

Keywords: Apex Systems, St. Paul , Quality Engineer II, Engineering , Saint Paul, Minnesota

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