Quality Engineer

About the Role

We are looking for an experienced Quality Engineer to join our team. In this role, you will utilize your skills as a member of a diverse team in providing technical support of commercialized product manufacturing. Your daily activities may include updating quality system documentation, aiding in product quality determinations, hands-on problem solving, and ensuring operator safety. You will be a part of cross-functional teams that ensure continued compliance with ISO and other global quality standards/guidelines that are applicable to implantable medical devices.

This role will be located at one of our facilities in Phoenix, Arizona with the possibility of a hybrid work arrangement.

Responsibilities

• Practice equitable and inclusive behaviors with other Associates to achieve outstanding results
• 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)
• Identify and address opportunities to continuously improve our manufacturing processes and assess opportunities for regulatory, quality, ergonomic, safety, environmental, and cost impact
• Employ statistical techniques to promote data driven decisions to establish sampling plans/troubleshoot/drive continuous improvement
• Partner with other engineers in a wide range of process projects throughout the development cycles: scale-up, validation, and improvement (improved safety, cost, quality, capability, and capacity)
• 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 of the GORE® PRECLUDE Pericardial Membrane and GORE-TEX® Cardiovascular Patch in addition to collaborating with other functions such as Quality Assurance, Manufacturing, and Regulatory in execution of work
• Apply formal problem-solving techniques to determine root cause in troubleshooting product non-conformances and developing and implementing corrective and preventative action (CAPA) plans
• 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)
• 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-conformance and CAPAs

Required Qualifications

• Bachelor’s Degree in Engineering or Science with minimum 3 years of hands-on engineering work experience
• Experience applying structured problem-solving approach (such as 8D, 8-Step, DMAIC or PDCA) that drives root cause analysis using 5-Why, Why Trees, and Fishbone analysis
• Knowledge in Product Risk Management (Risk identification, analysis, and mitigation methods)
• Ability to apply engineering fundamentals and statistical analysis to product quality support, optimization, and troubleshooting activities
• Ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables
• Ability to work effectively in team situations, building an inclusive environment, mentoring others as well as the ability to independently prioritize, initiate and drive projects to completion
• 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 document, communicate, and present technical bodies of work
• Ability to travel up to 5%

Desired Qualifications

• Minimum 3 years of relevant engineering experience in the Medical Device Industry
• Experience with applicable regulatory standards and quality system expectations (e.g., FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971)