Quality Engineer

About the Role

We are looking for a Quality Engineer to join our engineering team. In this role, you will utilize your skills as a member of a diverse team in providing technical support for commercialized product manufacturing. Your daily activities may include manufacturing process improvements, product quality determinations, hands-on problem solving, and ensuring operator safety.

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

Responsibilities

• Develop deep technical and historical knowledge of the product/product documentation to support quality processes (audit, change control) and drive the discovery of root causes in non-conformances and CAPAs
• Ensure continued compliance to ISO and other global quality standards/guidelines for product design and performance, addressing documentation gaps and updates (including documents such as FMEAs, ERT, PERC, etc.)
• Ensure design requirements are met by owning quality engineering design control deliverables and maintaining product Design History Files (i.e., Design input/output documentation, Risk management tools)
• Apply formal problem-solving techniques to determine root cause in troubleshooting product non-conformances and developing and implementing corrective and preventative action (CAPA) plans
• Identify and address opportunities to continuously improve manufacturing processes and assess opportunities for regulatory, quality, ergonomic, safety, environmental, and cost impact
• Employ statistical techniques to promote data driven decisions and to establish sampling plans/troubleshoot/drive continuous improvement
• Provide support and mentorship utilizing engineering principles and historical/materials/clinical/mechanical knowledge to ensure quality decisions are made related to product release and supplier quality
• Provide technical support for the manufacturing and collaborate with other functions such as Quality Assurance, Manufacturing, and Regulatory in execution of work
• Promote a diverse, inclusive, and respectful team environment

Required Qualifications

• Bachelor’s degree in Engineering or Science with a minimum of 1 year of hands-on engineering work experience post-graduation
• Knowledge in Product Risk Management (Risk identification, analysis, and mitigation methods)
• Experience applying structured problem-solving approaches (such as 8D, 8 step, DMAIC or PDCA) that drive root cause analysis using 5-Why, Why Trees and Fishbone analysis, etc
• Ability to effectively document, communicate, and present technical bodies of work
• Ability to apply engineering fundamentals and statistical tools to develop, optimize, and troubleshoot activities
• Ability to prioritize, plan, and drive projects from development to completion against agreed upon timelines/deliverables
• Ability to identify critical issues and failure modes, creating a framework of action to address these issues and assess root cause including effective risk-based decision making
• Ability to both work independently and collaborate effectively as part of a team
• Ability to travel up to 5%

Desired Qualifications

• Experience successfully interacting with cross-functional teams and influencing others with strong verbal and written communication
• Experience in a regulated industry and with quality systems, documentation, and methodologies and adverse event reporting or post market surveillance activities
• Experience and application of Lean methodologies and approaches