Strategic Partner

Operational Quality Systems Improvement Experts (OQSIE)

OQSIE is an execution-based consulting company with a focus in Life Sciences, helping clients since 2013. We're the premier problem-solvers supporting the industry, offering the highest value at the lowest cost.

OQSIE has expertise in Manufacturing, Quality Assurance, Regulatory Compliance, Supply Chain, and Operational Excellence and supports leaders in these functions with QMS gap assessments, audits, compliance remediation, program and project management, subject matter experts, real-time predictive analytics, bridging capacity and capability gaps, and other problem-solving activities relating to products and processes. 

OQSIE is a certified Minority-Owned Small Business headquartered in Southern California, serving the Americas, Europe and Asia. We are passionate about taking on difficult challenges that make significant and sustainable improvements in client's operating performance while striving to deliver extraordinary results.

Compliance Services: FDA 210 & 211 | FDA 820 | ISO 13485
• Authoring Standard Operating Procedures
• Compliance remediation (Responding to FDA Citations and Organize/Manage Programs) 
• Bridging Capacity/Capability Gaps at All Levels (Staff Augmentation) 
• Predictive Analytics and Technology Solutions