Quality Engineer - Medical Devices Job at Intellectt Inc, Buffalo Grove, IL

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  • Intellectt Inc
  • Buffalo Grove, IL

Job Description

Role: Quality Engineer – Medical Devices

Duration: 6-12+ Months

Location: Buffalo Grove, IL

What You’ll Do

  • Lead and manage Quality Assurance (QA) systems, including CAPA, audits, and compliance.
  • Ensure all products, processes, and records meet FDA, ISO 13485, and internal standards.
  • Collaborate cross-functionally to resolve quality issues and improve systems.
  • Analyze QA data, track trends, and report key metrics regularly.
  • Develop and deliver training on quality systems and best practices.
  • Serve as a lead representative during internal/external audits.
  • Investigate non-conformances and drive corrective actions.
  • Mentor and guide other QA team members.
  • Support global initiatives and maintain effective communication across teams.

What We’re Looking For

  • Bachelor’s degree in Engineering or a related technical field (advanced degree a plus).
  • 1-5+ years of QA or engineering experience in a regulated industry (medical device preferred).
  • Strong knowledge of FDA regulations, GMP, and ISO 13485.
  • Proven leadership in QA systems and cross-functional project teams.
  • Skilled in data analysis, reporting, and quality metrics.
  • Excellent communication and problem-solving skills.
  • Experience with CAPA management, audits, and risk assessments.
  • Certifications like ASQ CQE/CQA/CQT and Six Sigma preferred.

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