Precision – Integrity – Confidence
Partnering with biotechnology, pharmaceutical, and medical device organizations to strengthen compliance, achieve audit readiness, and drive leadership excellence. Founded by Rachel Kula, MS, CQA, and a former Fortune Top 50 "All Star" Company, Global Director of Quality. TQE helps companies build confidence through clarity, strategy, and proactive quality solutions that withstand any inspection.
20+
Years of Experience
100%
Inspection Success Rate
100+
Audits Completed
5
Industry Sectors
About Total Quality Excellence
Building Confidence Through Quality Excellence
Total Quality Excellence (TQE) is a fractional and full-time affiliated consulting group specializing in regulatory compliance, quality system development, and operational excellence across the life sciences sector. With more than two decades of leadership experience spanning biotechnology, pharmaceuticals, radiopharmaceuticals, and medical devices, we provide strategic insight and data-driven leadership, helping clients move from reactive compliance to proactive quality excellence.
Our mission is to partner with clients to build inspection-ready systems, foster a culture of continuous improvement, and drive sustainable business performance. Every engagement is guided by our founding principles of precision, integrity, and confidence—ensuring that quality is not only achieved but embedded throughout your operations.
Transformational
Quality Professional
TQE is led by a transformational Quality leader with over 20 years across biotech, pharma, and medical devices. We specialize in building scalable Quality Management Systems, elevating quality culture, and delivering confident, inspection-ready operations across clinical and commercial environments.
With deep experience across FDA, EMA, and global regulatory frameworks, we help organizations strengthen compliance, mature quality programs, and scale responsibly. Our approach blends quality strategy, hands-on execution, and a modern mindset—bringing digital, data-driven, and AI-enabled tools into the Quality ecosystem.
Above all, we believe quality is a capability, not a checkbox. We align teams, simplify complexity, and build systems and confidence that last well beyond the engagement—so organizations can grow boldly and operate with clarity, trust, and pride.
Our Services
Comprehensive Quality Solutions for Life Sciences
Audit & Risk Management
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Independent Lead Auditor, Internal, supplier, and third-party audits
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Risk management integration (FMEA, ICH Q9, ISO 14971)
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CAPA effectiveness and deviation reduction strategies
Vendor & Supplier Oversight
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Vendor qualification and performance management
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Quality Agreement development and oversight
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Compliance monitoring and audit response
Training & Leadership
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Inspection readiness training for global quality teams
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Leadership and quality culture development programs
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Auditor mentorship and certification support
Quality & Compliance Strategy
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Quality Management System (QMS) design, implementation, and optimization
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Regulatory inspection readiness (FDA, EMA, MDSAP)
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Quality culture and governance framework development
Professional Qualifications
American Society For Quality (ASQ)
ASQ Certified Quality Auditor (CQA)
MDSAP ISO 13485:2016
Medical Device Auditor (CMDA)
Relevant Training
Lean Six Sigma Green Belt
MDSAP Auditor Certification
Generative AI
Expertise & Regulatory Frameworks
Operating in Full Alignment with Global Standards
FDA 21 CFR Parts 210, 211, 820
ICH Q7, Q9, Q10
ISO 13485:2016 / ISO 14971:2019
MDSAP / EU MDR / IVDR
GxP (GMP, GLP, GCP) Compliance Audits
Professional Experience
Proven Track Record in Quality Excellence
Consultant to domestic and foreign entities in the core arenas of quality, compliance, medical device, product review, regulation/requirement integration, and risk management.
Affiliated Consulting Group
Providing fractional and full-time quality consulting services to life sciences organizations
Lead Auditor
Expert auditing services for biotech, pharmaceutical companies, and medical device manufacturers
FDA Remedial & Compliance
FDA inspection readiness, execution, and post-inspection support
Affiliated Consulting Group
Providing specialized quality consulting services to life sciences organizations
Lead Auditor (Medical Devices)
Expert auditing services for medical device manufacturers and pharmaceutical companies
FDA Remedial & Compliance
FDA remedial quality management system compliance activities, post-market surveillance activities, product complaint reviews, and Medical Device QMS assessments
Leadership in Action
TQE is led by Rachel Kula, a senior Quality executive with more than 20 years of experience in developing and leading global Quality and Compliance programs.
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Lead Auditor for pharmaceutical & medical devices
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Health Authority remediation CAPA activities and QMS GAP assessments
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Directing Quality Management Systems in world-class pharmaceutical organizations
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Building quality frameworks from the ground up for Start-Ups
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Leading Quality System initiatives across Medical Device, Biotechnology, and Gene Therapy companies
Rachel's expertise includes regulatory inspection readiness, supplier qualification, and eQMS implementation. Her leadership has guided organizations through successful FDA, EMA, and Health Canada inspections, CE Mark certifications, and ISO 13485 accreditations.
Industries We Serve
Specialized Expertise Across Life Sciences Sectors
Biotechnology
Pharmaceuticals
Medical Devices
Radiopharmaceuticals
Cell & Gene Therapy
INSIGHTS & RESOURCES
Thought Leadership in Quality Excellence
Let’s Discuss Your Quality Goals
If your organization is preparing for an audit, developing a new quality system, or pursuing operational excellence, Total Quality Excellence, LLC can provide the expertise and leadership to get you there.