Quality Assurance Specialist

4 weeks ago


Holdrege, Nebraska, United States Intellectt Inc Full time
Quality Validation Engineer

At Intellectt Inc, we are seeking a highly skilled Quality Validation Engineer to join our team.

Key Responsibilities:

  • Develop and implement quality validation processes to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to identify and mitigate quality risks.
  • Analyze data to identify trends and areas for improvement.
  • Develop and maintain quality documentation, including procedures and reports.
  • Provide training and support to colleagues on quality-related topics.

Requirements:

  • 3+ years of experience in quality assurance, including validation and quality engineering responsibilities.
  • Demonstrate success with statistical and problem-solving methodologies.
  • Excellent knowledge of quality engineering and management principles, as related to validation processes on medical devices.
  • Strong understanding of failure analysis, test methods, and engineering tolerances.
  • Strong verbal, written, and interpersonal skills.
  • Proficient with Minitab or other statistical software, MS Word, Excel, and MS Project.
  • Six Sigma Certification desired: ASQ CQE.
  • Working knowledge of 21CFR820, ISO 13485.
  • B.S. degree required.
  • B.S. degree in engineering (industrial, mechanical) desired.

Interview Process:

Onsite interview and tour. Typically, one visit for interview and tour, but may do a second.



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