I’m Annetta Odeh-Quirion — a certified ISO 13485 Lead Auditor and MBA-qualified consultant specializing in complaint management, risk mitigation, and regulatory compliance for medical devices and life science firms. Whether your team needs to reduce complaint backlogs, prepare for an audit, or improve your global quality system — I help you get compliant, stay compliant, and thrive in high-stakes environments.
Meet Annetta
With over 15 years in quality assurance and compliance, I’ve worked with leading companies like Pfizer, Olympus, Roche, and ACell to drive operational improvement in highly regulated environments. I'm passionate about helping organizations navigate complex compliance landscapes with confidence. I bring a calm, analytical, and collaborative approach to every project.
Like Sports event Omak Stampede
My Services
Complaint Management & Backlog Reduction
-
Root cause analysis
-
Reportability review
-
Remediation strategy
Regulatory Compliance & Risk Analysis
-
FMEA, Hazard Analysis
-
CE Marking files & MDR prep
-
SOP writing & policy development
Audit Readiness & CAPA Support
-
Internal audits (FDA, ISO, Health Canada)
-
Corrective action planning
-
Backroom audit support
Compliance Training
-
Onboarding modules
-
Custom workshops for QA/RA teams
Case Studies
Pfizer
Reduced open complaints from 7,000+ to under 4,500 in 6 months — enabling compliance with a key performance target.
Olympus:
Developed verification checklists for global complaint records and improved timeliness of MDR reporting. Supported 3rd Party suppliers in the EU with compliance to company global operating standards.
ACell:
Led CAPA/NCR process redesign; improved closure timelines by 40%. Achieved zero findings in ISO recert audit.