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
