Experienced Quality Engineer

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-conformance 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 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® CARDIOFORM Septal Occluder and CARDIOFORM ASD Occluder and collaborate with other functions such as Quality Assurance, Manufacturing, and Regulatory in execution of work
• Practice equitable and inclusive behaviors with other Associates to achieve outstanding results

Requirements

• Bachelor’s Degree in Engineering 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

Qualifications

• Direct experience in a quality, process, product or manufacturing engineering role post-graduation
• Experience in a regulated industry
• Experience with quality systems, documentation, and methodologies (for example, GMP, ISO 9001, APQP, House of Quality, etc)