Quality Engineer II

Position: Quality Engineer II

Role Overview: Supports global operations by ensuring quality standards, resolving customer issues, and driving continuous improvement. Collaborates with sales, operations, and customers to enhance performance, analyze data, and implement corrective and preventive actions (CAPA). Oversees customer complaint investigations, root cause analysis, and maintains compliance with Quality Management System (QMS) and ISO standards.

Key Responsibilities

• Manage Customer Health program, monitor KPIs, and facilitate root cause analysis.
• Lead resolution of quality issues across functions, using tools like 8D, 5-Why, and Fishbone diagrams.
• Analyze order process trends to reduce customer complaints and Field Quality Reports.
• Coordinate with internal teams and suppliers to address quality concerns and implement improvements.
• Support internal and external audits, ensuring ISO‑QMS compliance.
• Assist onboarding of new customers, developing project-specific processes.
  
  

Qualifications & Skills:

• Bachelor’s degree with 5–8 years of relevant experience.
• Experience in customer and stakeholder management, problem solving, and root cause analysis.
• Proficiency with quality tools (CAPA/8D, Lean/Six Sigma, DMAIC, FMEA).
• Knowledge of ISO 9001 and experience with process documentation.
• Strong communication and collaboration skills across global teams.
  
  

Preferred Qualifications: Knowledge of ISO 13485, medical regulations, auditing, or certifications like ASQ QE or Lean/Six Sigma.

Work Environment: Hybrid (3 days in-office), with occasional travel, based in Denver, CO.

Compensation: Competitive salary with benefits including health insurance, 401k, paid time off, and growth opportunities.