Principal Quality Engineer - Regulated Manufacturing & Compliance
Resume:
Deborah A. Hand
*******@*****.*** linkedin.com/in/deb-hand-8a310b4b/
PROFILE
Principal Quality Engineer with extensive experience in aerospace, medical devices, and regulated manufacturing. Proven expertise in software and hardware quality assurance, regulatory compliance (AS9100, 21 CFR 820), and supplier quality management. Recognized for driving process improvements, reducing risk, and mentoring teams to deliver best-in-class safety, compliance, and performance.
CORE COMPETENCIES
Quality Management Systems Software Quality Assurance Design Controls GMP & GDP Compliance CAPA & Root Cause Analysis Supplier Audits & Risk Management SPC & Process Validation Continuous Improvement Cross-functional Leadership Regulatory Compliance (AS9100, FDA 21 CFR 820)
PROFESSIONAL EXPERIENCE
Astronautics, Oak Creek, WI
Principal Quality Engineer – Design Assurance 2023 – Present
- Lead software design assurance verification and certification activities under multiple lifecycle methodologies (Waterfall, Iterative, Agile).
- Conduct inspections, testing, risk-based assessments, and project audits for system certification.
- Develop and execute software test cases and procedures for architecture design and system integration.
- Apply expertise with automation and performance testing tools (Selenium, Playwright, UFT, JMeter, LoadRunner) and data analytics (SQL, VBA).
Sientra Inc., Santa Barbara, CA
Quality Engineer 2021 – 2023
- Served as Quality lead for R&D projects, ensuring compliance with 21 CFR 820.30 design controls.
- Directed design verification, validation, and new process creation in support of medical device development.
- Represented Quality in cross-functional teams and design reviews, strengthening compliance and reducing risk.
Collins Aerospace (BE Aerospace), 2019 – 2021
Senior Quality Engineer 2019 – 2021 (Site closure Nov 2021)
- Managed AS9100 and AS9145 regulatory compliance, including audits and reporting to corporate control towers.
- Implemented Zero Defect Planning (ZDP) initiatives, supplier scorecards, and risk-based control plans.
- Reduced supplier non-conformances by driving 8D and RRCA corrective actions.
Carma Laboratories, 2017 – 2019
Contract Validation Process Engineer
- Directed validation of processes, equipment, and verification methods (IQ/OQ/PQ/PQ2, FMEA, APR).
- Improved process efficiency through enhanced engineering controls and risk-based validation.
Argon Medical Devices, 2013 – 2017
Senior Quality Engineer
- Oversaw new product introductions, extensions, and quality systems for interventional radiology and cardiology devices.
- Executed process validations and SPC implementation to optimize manufacturing processes.
- Improved supplier quality via risk-based performance ratings and incoming quality control metrics.
- Facilitated customer and regulatory audits, resolving complaints and nonconformances through effective CAPA.
Rockline (Contract), 2010 – 2013
Global Supplier Quality Engineer
- Conducted supplier audits for compliance and capability, improving vendor quality and regulatory readiness.
Bioform Medical, 2006 – 2010
Senior Quality Engineer
- Directed risk assessments, supplier audits, and validation protocols (IQ/OQ/PQ) for FDA submissions.
- Delivered management presentations on KPIs, trends, and performance improvement initiatives.
Bossard, Glendale, WI, 2004 – 2006
Quality Assurance Engineer / Account Manager
- Achieved 100% quality compliance through rigorous IFI standards testing.
- Streamlined part production flow using APQP and process redesign.
EDUCATION & CERTIFICATIONS
Business Studies, Radford University, VA
AAS, Textile Fabrication, FITechnology, New York, NY
United States Air Force (E5), USAF Veteran
Certifications: Six Sigma Green Belt Certified Quality Auditor (CQA, ASQ) Certified Quality Manager (CQM, ASQ) Validation Principles SPC FAIR PPAP Sampling Plans
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