ervice Overview:

With over 9 years of experience in the medical device and manufacturing sectors, I am a Certified Lead Auditor for ISO 13485 with expertise in Supplier Quality Management, Root Cause Analysis, and CAPA implementation. I specialize in quality management systems (QMS), regulatory compliance, and continuous improvement processes, ensuring high-quality standards across all stages of the product lifecycle.

Additionally, I offer Excel and Translation, Data Entry services with advanced skills in creating complex spreadsheets, macros, and data analysis, ensuring accurate and efficient data management.

Whether you need assistance with:

ISO 13485 audits and compliance
Supplier quality assessments and improvements
CAPA (Corrective and Preventive Actions) management
Root Cause Analysis and corrective actions
Post-market complaint handling and investigation
Process validation (IQ/OQ/PQ) and product inspections (FAT/SAT)
Process Failure Mode and Effects Analysis (PFMEA) and Risk Management
Automation tools for task assignment and process optimization
Excel Data Analysis, Excel Macros, Data Entry, and creating complex spreadsheets for reporting and analysis
I can help streamline your operations, reduce costs, and enhance product quality, ensuring that your organization remains compliant with regulatory standards such as FDA, EU MDR, and ISO 14971.

Why Hire Me?

ISO 13485 Certified Lead Auditor with hands-on experience conducting internal and external audits.
Proven track record of achieving operational efficiency and reducing costs (e.g., $50,000 savings through automation).
Expertise in Excel, including creating automated reports, macros, and data analysis for improved decision-making.
Experience with software tools such as Salesforce, ServiceMax, Trackwise, and SAP.
Expertise in quality tools including SPC, MSA, PFMEA, and 7QC tools.

I am committed to helping you achieve the highest standards in quality management, improve compliance, and reduce operational risks. I also specialize in providing data management solutions to ensure your business runs smoothly and efficiently.

Let’s collaborate to elevate your organization’s quality standards and operational excellence while simplifying your data management needs.

Work Terms

As Needed - Open to Offers