Douglas MacDonald

About Douglas MacDonald

Results-driven Quality Assurance and Compliance Professional with over a decade of experience in high-stakes, regulated environments. I specialize in quality auditing, supplier management, and material compliance, ensuring adherence to cGMP, regulatory standards, and organizational excellence. My career is defined by a relentless pursuit of operational efficiency, risk mitigation, and continuous improvement—driven by data, lean methodologies, and cross-functional collaboration.Core Expertise Quality Auditing & Compliance: Led 100+ inspections and audits, ensuring supplier/material compliance with FDA, cGMP, and ISO standards. Founded a Component Assessment Review Board, reducing onboarding time by 40% while eliminating animal-origin components from production. Supplier Quality Management: Overhauled Supplier Corrective Action Reports (SCARs) and Change Notification (SCN) processes, strengthening QMS and mitigating supply chain risks. Material Compliance & Risk Mitigation: Expert in material classification, risk assessments, and inventory accuracy (>98% KPI). Skilled in root cause analysis and lean principles (Six Sigma, 5S, Danaher Business System). Operational Leadership: Proven ability to streamline processes—cutting fulfillment time, boosting production output, and training teams in mock recalls and audit readiness.Why Work With Me?I bridge the gap between quality, compliance, and business growth. Whether leading cross-functional audits, optimizing supplier partnerships, or implementing lean workflows, I deliver measurable results under tight deadlines. My approach blends analytical rigor (proficient in MasterControl, NetSuite, Salesforce) with practical problem-solving—ensuring quality isn’t just a checkbox but a competitive advantage.Beyond the Resume Education: Dean’s List graduate (3.9 GPA) with a background in graphic design—uniquely blending creativity with precision in documentation and process design. Continuous Learner: Certified Quality Auditor (ASQ-CQA), Lean Six Sigma-trained, and avid LinkedIn Learning contributor.🤝 Community Focus: Volunteer for animal welfare and social causes, reflecting my commitment to accountability and impact beyond the workplace.Let’s connect to discuss quality innovation, supplier collaboration, or how to turn compliance into a strategic asset!

Experience

1. Quality Audit Manager

   Aldevron

   Dec 2025 — Present · Fargo, ND, US

Education

• Minnesota State Community and Technical College

  Associate's Degree

  2011 — 2013

• Minnesota State University, Moorhead

  Graphic Communications

  2013 — 2014