George Lane

Actively seeking a full time position in a fast-paced and innovative organization as a leader in Quality Engineering supporting quality, compliance, efficiency, and continuous improvement within medical device manufacturing and development projects. Driven to connect with clients and deliver value.

Quality Assurance Manager at Aptyx (2025-03 – Present)

Contract Medical Device Development and Manufacturing (Medical Murray Acquired by Aptyx)

• Served as site management representative
• Led the team through multiple successful high-profile audits including ISO-13485 initial certification and surveillance, EU MDR QMS audit, and FDA pre-approval inspections
• Facilitated a kaizen event and a tiger team to support continuous improvement and organizational problem solving
• Spearheaded initiative to achieve Brazilian ANVISA GMP compliance through regulatory gap assessment and strategic planning of improved QMS processes
• Managed site initiative to achieve compliance to upcoming 21CFR Part 820 harmonization with ISO 13485
• Supervised and mentored a team of one supervisor, 7 engineers, 5 technicians, and 6 inspectors
• Overhauled the organization's cleanroom control and monitoring regime for increased control and alignment with current industry expectations
• Collaborated with customers on regulatory submissions and responses to support timely approval and resolution of concerns from reviewers

R&D Quality Engineering Team Lead at Medical Murray (2024-03 – 2025-03)

Contract Medical Device Development and Manufacturing

• Independently performed lead auditee responsibilities for several external audits including notified bodies for ISO 13485 and EU MDR
• Demonstrated confidence, problem solving skills, and customer service skills by stepping up to effectively de-escalate and resolve high-stakes quality and compliance challenges
• Performed lead auditor responsibilities for multiple audits supporting qualification of suppliers
• Performed lead auditor responsibilities for company-wide internal audit
• Recruited, hired, on-boarded, and mentored a successful team of 3 talented and well-respected R&D Quality Engineers
• Established and maintained strong working relationships with direct reports through weekly 1 to 1 meetings
• Tactically and effectively delegated project assignment responsibilities through quantitative and qualitative assessment of team workload
• Led Quality Engineering team to reduction of company rolling open NCR count by 85%
• Provided direct support of FDA audit in auditor-facing role
• Spearheaded data-driven QMS improvements with a philosophy of simplicity and clear definition of terminology to promote organizational efficiency, quality, and compliance resistant to rapid organizational scale up
• Consistently challenged status quo and motivated peers and direct reports to strive for excellence
• Performed MRB approver responsibilities ensuring appropriate disposition of nonconforming material

R&D Quality Engineer 2 at Medical Murray (2023-08 – 2024-03)

• Pioneered new role and department which improved efficiency of quality and compliance in key development projects by streamlining deliverable creation and review with early input from Quality
• Improved quality of design output documentation through detailed review, interactive feedback, and creation of an improved process for communicating engineering change order feedback
• Collaborated with R&D project teams to plan sampling inspections and employ lean six sigma statistical techniques for engineering testing such as descriptive statistics, histograms, distribution identification, process capability analysis, t-tests, tolerance limit analysis, and binomial attribute confidence/reliability
• Developed in-house calibration approach for Zeiss O-Inspect system which delivered over $5,000 of cost savings per system per year
• Actively mentored engineering team on quality topics including applicable standards/regulations, statistical techniques, metrology, risk management, design verification and validation, design for manufacturing, and process validation
• Identified areas for improvement of design control processes to mitigate risk of uncontrolled design changes through internal audit that were well received by top management and implemented
• Demonstrated efficiency and time management skills by supporting over 30 R&D projects at once as the only R&D Quality Engineer in the organization
• Created concept for and designed low-cost Zeiss O-Inspect fixtures using layered laser-cut transparent polycarbonate which allow for multi-orientation fixturing of components which would otherwise require an expensive CT system

Quality Engineer 1 at Medical Murray (2021-10 – 2023-08)

• Developed novel approach to link risk management outputs to statistical techniques for verification and validation testing for cost-optimization and improved occurrence scoring
• Developed, implemented, and sustained statistical process control plans to identify and implement process improvements
• Supported nonconformance process through personal execution, training, and advising project engineers
• Built strong and trusting working relationships with hourly quality personnel

Manufacturing Quality Engineer at Cook Medical (2019-09 – 2021-10)

Medical Device Manufacturing

• Supported manufacturing quality of medical devices
• Investigated process events, containment scoping, and identified corrections
• Triggered reduction of complaints and nonconformances through design and process improvements
• Performed CAPA duties including investigation planning, root cause investigation using tools such as 5 Whys and Fishbone analysis, action planning, action implementation, and verification of effectiveness testing using 8D problem solving method
• Integrated in-process quality inspections for scrap-cost reduction in continuous flow lines
• Performed quality trending to identify opportunities for quality improvements, risk reduction, and cost savings

Bachelor of Science in Biomedical Engineering; Biomechanics Concentration – NC STATE UNIVERSITY/UNC CHAPEL HILL, Joint Dept. of Biomedical Engineering (2019-05)