Quality Assurance Engineer

JAY BELTZ

Leominster, ***** Massachusetts 978-***-**** ***.*****@*****.***

Summary

Experienced Quality Assurance Engineer with over 25 years of expertise in V&V testing, test design optimization, and software testing for systems across industries such as medical devices, financial software, and biotechnology manufacturing. Proven success in enhancing product reliability, defect leakage by up to 40%, and streamlining QA processes to improve efficiency. Skilled in both manual and automated testing, process improvement, and ensuring compliance with regulatory standards. Known for leading cross-functional teams, and delivering high-quality results on time.

Skills

• Test planning and execution.

• Automated testing (e.g., Selenium, JUnit, Cypress)

• Manual testing and defect tracking

• SQL and database validation

• API testing (e.g., Postman, REST Assured)

• SDLC and Agile/Scrum methodologies

• Performance and load testing (e.g., JMeter, LoadRunner)

• Bug reporting and triage (e.g., JIRA, Bugzilla)

• Regression and integration testing

• Test case design and documentation.

• Version control tools (e.g., Git, SVN)

• Compliance and validation standards

Experience

Senior Software Quality Assurance Engineer 02/2022 to Current Quanterix Billerica MA

• Authored and implemented over 100 IQ/OQ/PQ protocols for commercial off-the-shelf (COTS) software, ensuring full compliance with ISO 13485 and 9001 standards, and enabling seamless software qualification across R&D and production.

• Spearheaded cross-functional initiatives with MFG Engineering to qualify 10 or more new manufacturing systems, reducing validation cycle times by 40%, while enhancing equipment reliability and audit readiness.

• Directed the development of dFMEAs and pFMEAs across five high-priority product lines, leading to a 35% reduction in customer-facing quality issues by proactively identifying and mitigating critical design and process risks.

• Built and optimized JIRA- and Excel-based QA tracking tools that streamlined the capture and analysis of non-conformances and deviations, improving issue resolution time by 50%, and enhancing trend visibility across product lifecycle stages. Senior Manager System Quality Assurance (V&V) 06/2015 to 01/2022 Quanterix Billerica MA

• Founded and scaled Quanterix's Verification & Validation (V&V) department, hiring and leading a high-performing team of six (two scientists, four test engineers), resulting in the successful execution of formal V&V protocols across three novel RUO biomarker detection platforms (HD-X, SR-X, SP-X).

• Authored and implemented over 50 formal test plans and reports, increasing testing coverage by 40%, and ensuring FDA-aligned V&V compliance for next-generation ultra-sensitive diagnostic systems.

• Designed and deployed a centralized test infrastructure to manage over 1,000 test cases, defects, and procedural documents, cutting test case retrieval and reporting time by 60%, and enhancing cross-team transparency.

• Led hiring, training, and performance development for the entire V&V organization, creating 100% of SOPs and role definitions, while personally conducting 20+ candidate interviews, and driving a 90% employee retention rate. Senior Quality Assurance Engineer 04/2010 to 06/2015 AIR Worldwide Boston MA

• Developed and executed 300+ automated and manual test cases—including acceptance, numerical regression, performance, and antagonistic tests—improving overall test coverage by 45% for stochastic catastrophe modeling software.

• Mentored 5+ junior QA engineers, streamlining their daily workflows, and improving team testing efficiency by 30%, while presenting clear, data-driven QA metrics to cross-functional stakeholders.

• Engineered robust automation scripts using SQL, SpecFlow, and Silk4Net, enabling the execution of hundreds of regression tests per release cycle, and reducing manual testing time by 60%.

• Led quality assurance process improvement initiatives across Agile, Scrum, and Kanban teams, contributing to a 25% reduction in post- release defects, and accelerating feedback loops for new product features. Senior Product Evaluation Group Engineer 02/2007 to 04/2010 Hologic Inc. Marlborough MA

• Designed and executed 100+ V&V test procedures for complex medical devices—including robotic systems, SQL databases, and UI components—ensuring FDA compliance, and reducing validation cycle time by 25%.

• Proactively identified requirement gaps and risk factors during early development stages, mitigating potential test delays, and decreasing defect leakage into production by 40%.

• Led defect triage meetings across cross-functional teams, authored over 200 detailed and reproducible defect reports, and drove resolution efforts that cut critical bug turnaround time by 30%.

• Accurately estimated test effort and resource needs for multiple concurrent projects, enabling on-time testing delivery with limited capital equipment and staffing, and improving test planning efficiency by 35%. Product Test Group Supervisor 03/2001 to 02/2007

Caliper Life Sciences Hopkinton MA

• Supervised daily operations of the Product Test Group, overseeing QA efforts across 5+ concurrent drug discovery instrument projects, and improving test team efficiency by 30% through optimized resource allocation.

• Authored and executed 50+ validation test plans and procedures for robotic laboratory systems, ensuring compliance with 21 CFR Part 11, and accelerating regulatory readiness for commercial release.

• Implemented robust defect tracking and escalation workflows across multiple product lines, reducing unresolved critical bugs at launch by 40%, and enhancing cross-functional communication with engineering and management.

• Developed and standardized 10+ manufacturing SOPs and validation documents, directly supporting production teams during product escalations, and ensuring a seamless transition from R&D to manufacturing. Applications Engineer 03/2000 to 03/2001

Panametrics Inc. Waltham MA

• Led the successful deployment of over 100 ultrasonic flow meter systems across diverse industrial applications nationwide, delivering tailored, non-intrusive solutions that improved clients' process efficiency by up to 20%.

• Analyzed customer process data and technical parameters to accurately size and quote flow meter systems, contributing to a 15% increase in closed sales through precise engineering consultation.

• Delivered on-site technical support and direct training to over 50 clients and 10+ new hires, enhancing customer satisfaction, and reducing post-installation service requests by 35%.

• Authored detailed operational and installation guidelines for ultrasonic flow meter products, standardizing support processes, and shortening onboarding time for new engineers by 25%. Data Services Specialist 07/1999 to 03/2000

Interactive Data Corporation Bedford MA

• Investigated and resolved over 100 suspicious trade anomalies weekly across major North American stock exchanges, ensuring data accuracy and regulatory compliance for global financial clients.

• Conducted routine audits of financial databases using UNIX-based tools, improving data integrity, and reducing critical discrepancies by 30% over a 12-month period.

• Collaborated with a cross-functional team to address daily market data issues, contributing to a 25% improvement in issue resolution time, and enhancing real-time financial data reliability.

• Streamlined validation workflows by identifying inefficiencies in existing processes, leading to a 15% reduction in manual review time, while maintaining 99.9% data accuracy.

Technical Support Supervisor 12/1998 to 07/1999

Protocol Communications Leominster MA

• Built and led a new technical support department from the ground up, hiring and training a team of 15+ support specialists, which reduced the average call resolution time by 35% within the first six months.

• Co-developed and implemented scalable call support infrastructure, procedures, and troubleshooting tools, resulting in a 40% increase in first-call resolution rates, and improved client satisfaction scores.

• Maintained and expanded the internal knowledge base with over 200 troubleshooting entries, enhancing team efficiency, and decreasing onboarding time for new staff by 50%.

• Established standardized training programs and performance metrics for support agents, leading to a 20% improvement in team productivity, and a measurable reduction in support escalations. Education and Training

BS: Chemical Engineering, Chemistry, Process Control Automation 01/1998 University of Massachusetts Lowell (UMASS)

Bachelor of Science in Chemical Engineering, with a Minor in Chemistry & concentration in Process Control Automation MS: Chemical Engineering, Biotechnology 01/1996

University of Massachusetts Lowell (UMASS)

Master of Science in Chemical Engineering, with a concentration in Biotechnology Accomplishments

• Biological assay validation, Assisted with sample automation: ELISA enzyme immunoassay, many other types of gene expression assays.

• Biotechnology instrument testing, High level of experience in verification/validation/integration testing for various biotech instruments.

• 10 years of experience as a JIRA Site Admin for the entire company. Designed over 100 ‘company managed’ complex JIRA projects need to report project statuses, analytical trending, and employee accountability.

• Software development, successfully made my team's job easier and faster at Panametrics Inc.

• Thesis, Control of a Nonlinear pH Process Using Generic Model Control (GMC).

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