Quality Engineer

We are looking for an experienced Quality Engineer to join in Gore Medical. In this role, you will provide critical daily support to manufacturing, drive improvements to yield, ergonomics, and productivity, ensure continued compliance with ISO and other global quality standards/guidelines applicable to implantable medical devices, and help the team scale for future business growth.

This position will be located at our facility in Elkton, Maryland, with the possibility of a hybrid remote work arrangement.

• Provide technical support for commercialized product manufacturing
• Apply formal problem-solving techniques to assess root cause, troubleshoot non-conforming products, raw materials, and components, and develop and implement corrective and preventative action (CAPA) plans
• Identify and address opportunities to continuously improve our products and processes, targeting yield, capacity and ergonomic improvements
• Assure product quality across the supply chain by evaluating non-conforming material, identify and resolve quality issues, and implement process/product changes
• 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)
• Champion risk-based decision making based on deep technical and historical knowledge
• Validate test methods and products, and develop visual standards and sampling plans
• Effectively collaborate and influence on cross-functional teams including product specialists, supply chain, manufacturing, regulatory, and quality

• Bachelor's Degree in Engineering or Science with a minimum of 3 years of hands-on engineering experience supporting a manufacturing organization
• Experience applying structured problem-solving approach (such as 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)
• Demonstrated ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables
• Demonstrated ability to effectively interact and influence cross-functional teams, as well as work independently
• 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 apply engineering fundamentals and statistical analysis to product quality support, optimization, and troubleshooting activities
• Ability to document, communicate, and present technical work effectively
• Ability to travel up to 5%

• Experience in a regulated industry and with quality systems, documentation, and methodologies and adverse event reporting or post market surveillance activities
• Direct experience in a quality, process, product, or manufacturing engineering role post-graduation

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.