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Quality Engineer - Medical Device

Jabil

Salary not specified
Aug 27, 2025
West Chester, PA, USA
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At Jabil, the business problem is to ensure compliance with internal and regulatory standards, drive continuous improvement, enhance customer satisfaction, and contribute directly to product and process excellence.

Requirements

  • Strong understanding of quality system regulations and standards.
  • Proficient in statistical analysis tools and techniques.
  • Skilled in using PC-based systems including Microsoft Office and quality management software.
  • Experience with inspection planning, control plans, and validation in a regulated environment.
  • Familiarity with Six Sigma or other structured problem-solving methodologies.
  • Working knowledge of complaints handling, document control systems, and inventory management tools.
  • Certification in Quality Engineering (e.g., CQE) is a plus.

Responsibilities

  • Conduct root cause analyses for quality issues using tools such as 8D, A3, and Six Sigma.
  • Perform statistical analyses including ANOVA, DOE, Weibull, GR&R, capability studies, FMEA, and TMV.
  • Evaluate, design, and implement inspection and process control systems.
  • Assist in validation activities for processes, equipment, software, and computerized systems.
  • Prepare and maintain clear documentation including protocols, reports, and procedures.
  • Support new product introductions and process transfers.
  • Participate in complaint investigations, nonconformances, and CAPA activities.

Other

  • Bachelor’s degree required; Engineering or related technical field preferred.
  • Minimum of 2 years of relevant experience in Quality Engineering or a regulated manufacturing environment.
  • Excellent written and verbal communication skills.
  • Strong decision-making, organizational, and problem-solving abilities.
  • Ability to work independently and collaboratively across teams.