Cook Group

Quality Engineer

Cook Group

full-time

Posted on:

Location Type: Office

Location: Bloomington • United States

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About the role

  • Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, and other applicable standards.
  • Act as the primary contact for quality issues, interfacing with internal teams and external stakeholders.
  • Conduct risk assessments and develop risk management documentation, including FMEAs.
  • Lead investigations into product non-conformances and complaints, performing root cause analysis and implementing CAPAs.
  • Review and approve change requests, ensuring compliance with quality standards.
  • Collaborate with cross-functional teams to drive quality improvements and product enhancements.
  • Support internal and external audits, providing documentation and ensuring audit readiness.
  • Analyze quality data to identify trends and opportunities for process improvements.
  • Support product lifecycle activities from design to post-market surveillance, addressing product-related risks.
  • Provide guidance and mentorship to entry-level technical staff.
  • Interface with regulatory bodies and third-party auditors, such as FDA and Notified Bodies.
  • Manage conflict resolution related to technical quality issues.
  • Maintain all required training and seek continuous professional development.

Requirements

  • Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
  • 2-3 years of experience in quality engineering within a regulated industry, preferably medical devices.
  • Proficiency in statistical analysis, quality tools, and methodologies (e.g., Six Sigma, FMEA).
  • Strong understanding of medical device regulations (ISO 13485, 21 CFR 820, ISO 14971).
  • Excellent communication skills, both verbal and written.
  • Strong organizational skills with attention to detail and critical thinking.
  • Project management experience and ability to work independently.
  • Professional certification (e.g., ASQ, Six Sigma) preferred.
  • Proficiency in Microsoft Office Suite.
Benefits
  • Maintain compliance with safety policies and a safe work environment
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
statistical analysisquality toolsSix SigmaFMEAroot cause analysisCAPArisk managementquality data analysisproduct lifecycle managementchange request review
Soft Skills
communication skillsorganizational skillsattention to detailcritical thinkingproject managementconflict resolutionmentorshipcollaborationindependent workinterfacing with stakeholders
Certifications
ASQSix Sigma