Experienced Quality Management System Technician

We are looking for a Quality Management System Technician to join our team in Flagstaff. Associates in this position independently manage quality system activities and manufacturing quality processes. This role serves as a subject matter expert for quality system processes while partnering with Quality Assurance, Manufacturing, Engineering, Regulatory Affairs, and Product Specialist teams to ensure compliance, risk-based decision making, and continuous improvement.

This role will be located at our Echo Ridge facility in Flagstaff, Arizona. ​​ 

• →Manage complex quality system records including Non-Conforming Reports (NCRs), Change Orders (COs), Corrective Action and Preventative Action (CAPAs) investigations, and related manufacturing quality activities.
• →Lead cross-functional investigations utilizing formal root cause analysis methodologies and drive effective corrective actions.
• →Serve as a subject matter expert for assigned Quality Management System processes while working cross-functionally with Quality Assurance, Manufacturing and Engineering.
• →Analyze quality system trends and identify opportunities for systemic improvement.
• →Support regulatory inspections, internal audits, and external audits and effectively represent quality system records.
• →Mentor and provide guidance to other associates regarding QMS requirements and investigation practices.
• →Create and maintain strong cross functional partnerships while driving accountability to commitments and timelines.
• →Maintain compliance with required training and team/function expectations.
• →Shift focus and manage workload based on a dynamic environment with changing priorities.
• →Additional responsibilities as required within the scope of the position.

• Associate degree or equivalent in Engineering Technology, Manufacturing Technology, Applied Science, Life Sciences, or related technical discipline. Additional relevant experience may be considered in lieu of formal education.
• Minimum 3 years of experience in a regulated manufacturing environment.
• Minimum 3 years of direct experience working within a Quality Management System supporting medical device, pharmaceutical, biotechnology, aerospace, or similarly regulated industries.
• Experience independently managing NCRs, Change Orders, investigations, CAPAs, or equivalent quality system records.
• Experience leading cross-functional investigations and root cause analysis activities.
• Working knowledge of FDA Quality System Regulations, ISO 13485, GMP requirements, and risk management principles.
• Strong technical writing skills with experience developing SOPs, investigations, and quality documentation.
• Proficiency with PLM systems, Microsoft Word, and Microsoft Excel.
• Demonstrated ability to influence cross-functional teams.
• Strong analytical, critical thinking, prioritization, and problem-solving skills.