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Quality Engineer

Quality Engineer

Katalyst HealthCares & Life SciencesWheeling, IL, US
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Responsibilities

  • Provide comprehensive quality support for operations and NPI activities, ensuring compliance with ISO 13485 (or AS9100 / IATF 16949) and FDA CFR820 standards.
  • Lead and document root cause analyses, CAPA, and nonconformance investigations for customer complaints, supplier issues, and nonconforming materials.
  • Support and document validation efforts (IQ / OQ / PQ) for processes, equipment, and products; maintain validation documentation.
  • Perform capability studies (Cpk), FMEA, and advanced metrology practices (GD&T); analyse and organize data using Minitab, Excel, and related tools.
  • Resolve customer complaints and product issues, maintaining professional communication and data-driven solutions.
  • Collaborate with inspectors and technicians on product inspection and testing using vision systems, CMMs, calliper's, micrometres, and more.
  • Interface with suppliers and internal teams to drive process improvements, maintain documentation control, and foster a continuous improvement culture.
  • Ensure all quality activities align with regulatory, customer, and internal requirements; participate in internal and external audits.

Requirements

  • Bachelor's degree in engineering required.
  • Minimum 8 years of quality engineering experience in medical device manufacturing (aerospace or automotive experience also considered).
  • Expertise in ISO 13485, FDA CFR820, AS9100, or IATF 16949 standards.
  • Proven experience leading CAPA, Client activities, and validations in manufacturing settings.
  • Experience collaborating with customers to resolve complaints and product issues.
  • Advanced knowledge of metrology, GD&T, and interpreting CAD / blueprints.
  • Hands-on experience with industrial machinery such as CNC, EDM, and finishing equipment preferred.
  • Proficient in Minitab, Excel, and technical documentation software.
  • Strong leadership, communication, and process ownership skills.

    • Katalyst HealthCares & Life Sciences

    J-18808-Ljbffr

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    Quality Engineer • Wheeling, IL, US