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Seeking a Senior Quality Engineer to join our team. Quality engineers assist in the planning, development, implementation, communication, and maintenance of a company's quality management systems, polices, documentation, data, and customer-specific requirements.

About the Role:

  • Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
  • Establishes statistical confidence by identifying sample size and acceptable error and determining levels of confidence.
  • Develops experiments by applying full and fractional factorial techniques.
  • Develops sampling plans by applying attribute, variable, and sequential sampling methods.
  • Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes.
  • Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
  • Prepares reports by collecting, analyzing, and summarizing data; and making recommendations.
  • Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, participating in professional societies, and maintaining ASQ-certified quality engineer qualification.
  • Contributes to team effort by accomplishing related results as needed.
  • Ensures products adhere to company and industry quality standards.
  • Brainstorms ideas to create solutions for identified problems.

About You:

  • Bachelor's degree in engineering or equivalent discipline or equivalent work experience.
  • 5 years minimum hands-on working knowledge of the FDA QSR and ISO 13485 required.
  • 5+ years in a manufacturing environment preferred.
  • Experience with:
    • Test methods and standards for the design, verification, and validation of medical device products.
    • Risk management, and risk assessment techniques, such as FMEA, fault tree analysis, 5 Why's, Fishbone analysis, etc.
    • Root cause analysis experience preferred.
    • Development of inspection and work instructions.
    • Part inspection, including layout, in process, final, and receiving using all types of mechanical inspection.
    • Preparation of inspection reports.
    • Coordination and performance of internal process/product audits.
    • Performance process capability studies.
    • Programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and performance of gage R&R studies preferred.
  • Good oral and written communication skills.
  • Ability to communicate effectively with all levels of staff and management, both internal and external.
  • Capacity to work independently from general supervision (must be self-motivated once given direction/guidance).
  • Excellent organization skills with the ability to perform multiple tasks and obtain results working within strict time frames.
  • Strong attention to detail.
  • Proficient in MS Office software including Word, Excel, and PowerPoint.
  • Ability to read and interpret assembly and component drawings and engineering specifications.
  • CAD Data Analysis (measurement & manipulation).
  • Basic knowledge of operating measurement equipment (CMM preferred).
  • Good knowledge of manufacturing processes.
  • Above average math skills (sound knowledge in both statistics and calculus).