Quality Engineer

We are looking for a talented Laboratory Quality Engineer to join our dynamic team. In this role, you will enhance laboratory operations by maintaining and optimizing analytical test methods to ensure they meet rigorous standards of safety, effectiveness, compliance, and efficiency. You will work closely with cross-functional teams; including Engineering, Research & Development, Manufacturing, and Quality Assurance to deliver comprehensive root cause analyses and drive quality improvement initiatives. Additional responsibilities will include driving validation activities, conducting trend reviews, managing quality investigations, and promptly addressing issues to ensure smooth lab operations.

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

• Optimize and maintain analytical test methods to ensure laboratory adherence to safety, regulatory compliance, and efficiency standards
• Update and maintain risk documentation through continuous evaluation of current data to support effective operations
• Apply statistical techniques to enable data-driven decision making in daily operations and continuous improvement endeavors
• Collaborate with cross functional teams to conduct thorough root cause analyses for in-process rejections and data trends
• Build comprehensive technical expertise in laboratory test methods and equipment validations to support audits, change control, and pFMEAs
• Document and communicate technical plans, experimental results, and conclusions of work to satisfy quality system requirements and enable future use of knowledge
• Lead or support quality investigations related to NCRs, CAPAs, and LQEs to maintain laboratory operations
• Support material qualification and validation planning, as well as drive and support equipment, software, and method validation processes
• Identify, lead, and support continuous improvement projects to drive excellence in lab functions
• Routinely evaluate critical quality processing factors (environmental conditions, process inputs, process control equipment, etc.) to mitigate risk of impact on operations

• Bachelor's degree in Engineering with a minimum of 3 years of engineering work experience
• Experienced in reviewing, approving, and managing documentation in a quality system (e.g., SOPs, protocols, reports, and WPs)
• Demonstrated compliance to regulatory requirements (e.g., governing quality systems, product safety, and cGxP)
• Ability to prioritize, plan, and drive multiple projects concurrently from development to completion in accordance with agreed upon timelines and deliverables
• Ability to apply engineering fundamentals and statistical analysis to drive/support product quality, trending, improvement, and troubleshooting; ability to support external and internal audits
• Demonstrated ability to identify, analyze, and resolve complex quality issues by applying structured problem-solving methodologies and risk analysis tools
• Ability to foster and maintain strong collaborative working relationships on team and cross functionally (Engineering, Manufacturing, R&D, QA, QCU, QC, Product Specialist, IT)
• Ability to make effective risk-based decisions, including the use of pFMEAs
• Ability to effectively document, communicate, and present technical bodies of work to a diverse group of Associates
• Ability to work in a dynamic, fast paced laboratory setting where experimental inputs and expected outcomes may be uncertain or evolving and to travel up to 5%

• Experience in Project Management and utilizing structured PM tools/methodologies such as MS Project, WBS establishment, and Critical Path identification
• Demonstrated application of lean Six Sigma methodologies such as statistical process control (SPC), pareto charts, and failure analysis
• Familiarity with standards and regulations relevant to combination products, such as FDA 21 CFR Part 4, ISO 13485 guidelines