Quality Professional with extensive experience in
Medical Device manufacturing
Quality Professional with extensive experience in
Medical Device manufacturing
I am a Quality and Regulatory professional with extensive experience driving compliance, efficiency, and risk management across the medical device, diagnostic, and SaMD industries. My expertise spans Quality Management Systems (QMS), Supplier Quality Engineering, regulatory compliance, and product lifecycle management — from early-stage development through commercial manufacturing.
I have led the design, implementation, and optimization of global QMS frameworks in alignment with ISO 13485, ISO 9001, ISO 14971, 21 CFR Part 11/820, and GMP requirements. My work includes building phase-appropriate systems for startups, scaling processes for growth-stage companies, and strengthening compliance in established organizations. I bring a strong track record of leading cross-functional initiatives in CAPA, audits, risk assessment, supplier qualification, and change management.
As a certified Quality Manager/Organizational Excellence (CQM/OE), Six Sigma Green Belt (DMAIC), and IBM Certified AI Developer, I also integrate data-driven process improvement and emerging technology into quality strategies. My approach balances regulatory rigor with business needs, enabling organizations to achieve sustainable compliance while accelerating innovation.
I thrive in both consulting and full-time roles, and I am open to opportunities where I can apply my skills to advance patient safety, product quality, and organizational excellence.
Available immediately for remote/hybrid work.
Would consider relocation for the right opportunity.
Please also see me at: https://dmcelroyinfo.com
2826 E Alluvial Ave, Unit 102, Fresno, California 93720, USA
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