Quality Engineer

Location: On-site in Fort Collins, CO

This position will remain open until filled.

• Own and maintain the organization's metrology and calibration systems, ensuring measurement accuracy, traceability, and compliance with ISO 13485 requirements.
• Develop, implement, and continuously improve calibration programs, including calibration intervals, asset tracking, documentation, and coordination of external calibration service providers.
• Plan, execute, and evaluate Measurement System Analysis (MSA) activities, including Gauge R&R, bias, linearity, and stability studies to ensure measurement system capability.
• Develop and maintain inspection plans, inspection methods, sampling strategies, and quality control techniques to support manufacturing and inspection processes.
• Perform statistical analyses, including Statistical Process Control (SPC), capability studies, Design of Experiments (DOE), and trend analysis to support process improvement and product quality objectives.
• Support product and process validation activities by ensuring measurement systems are validated, capable, and appropriate for intended use.
• Lead and support investigations related to measurement system performance, nonconforming, products, and quality issues through root cause analysis, corrective actions, and preventative actions (CAPA).
• Coordinate and participate in Material Review Board (MRB) activities to evaluate nonconforming materials, determine product disposition, and support associated corrective actions.
• Monitor, analyze, and report calibration performance metrics, measurement system effectiveness, inspection data, product returns, and quality trends to support continuous improvement initiatives.
• Serve as a Quality Engineering liaison for internal and external customers, supporting quality-related activities, PPAP documentation, and cross-functional quality improvement efforts.
• Maintain quality records, controlled documents, and supporting documentation within applicable quality management systems to ensure compliance with internal procedures and regulatory requirements.
• Lead and support risk management activities in accordance with ISO 13485 and applicable regulatory requirements.
• Ensure compliance with ISO 13485 standards, company Quality Management System (QMS) requirements, and applicable regulatory expectations.
• Support the onboarding, training, and development of interns and other team members by providing guidance on quality systems, metrology practices, inspection methods, and engineering best practices.
• Perform other duties as assigned.

• Bachelor’s degree in engineering or related field; equivalent experience may be considered.
• Minimum of 3-5 years of manufacturing experience, preferably in injection molding or ISO-regulated manufacturing environments.
• Six Sigma Green Belt certification or equivalent continuous improvement training preferred;
  Six Sigma Black Belt certification is a plus.
• Strong knowledge of quality engineering principles, including statistical analysis (MSA), and process control methodologies.
• Experience utilizing statistical tools and quality methodologies, including Statistical Process Control (SPC), Design of Experiments (DOE), capability analysis, and root cause analysis.
• Ability to interpret technical drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T) requirements.
• Experience working with metrology systems, calibration management systems, and inspection equipment to ensure measurement accuracy and compliance.
• Experience working within ISO-regulated Quality Management Systems (QMS) and regulated manufacturing environments preferred.
• Knowledge of quality assurance practices, product validation, risk assessment, and regulatory compliance requirements.
• Strong organizational, analytical, and problem‑solving skills with high attention to detail.
• Ability to manage multiple priorities, meet deadlines, and work independently with minimal supervision.
• Strong verbal, written, and interpersonal communication skills, with the ability to collaborate effectively across departments.
• Proficiency in basic mathematical calculations, statistical analysis,…