Gretchen Olson Email & Phone Number

Morgan Hill, California, US

• Site Management Representative and Person Responsible for Regulatory Compliance
• Manage Quality and Regulatory activities for MDR transition, to include creation and maintenance of Technical Documentation
• Ensure the maintenance of the quality system in compliance with FDA, ISO, MDR, and other regulations, standards, and internal procedures.
• Lead and maintain Internal Audit program to verify compliance with 21CFR 820 and ISO 13485:2016, and MDR 2017/745
• Administer and lead CAPA systems from initiation to effectiveness review.
• Develop and maintain Quality Metrics to assess the performance, effectiveness, and overall quality of product and processes.

Carlsbad, California, US

• Manage Quality and Regulatory activities for New Product Introduction
• Ensure the maintenance of the quality system in compliance with FDA, ISO and other regulations, standards, and internal procedures.
• Ensure compliance to the Quality System: Document control, complaint handling, CAPA systems, and training systems.
• Manage the Quality Department, including Quality Control and Document Control
• Direct quality planning and risk management activities for new and modified products as a part of the design control process
• Ensure that Design Control procedures are followed. Prepare (DHF) Design History File for design control projects.

Memphis, Tennessee, US

• Manage Quality Assurance staff of 4 to ensure customer expectations are met in regard to quality of Intermediate Raw Materials. Ensure regulatory compliance for global product distribution.
• Successfully transitioned 2 sites from ISO 9001:2008 to ISO 13485:2016 certification
• Lead and maintain Internal Audit program to verify compliance with 21CFR 820 and ISO 13485:2016, EC1069/2009, and USDA
• Lead and maintain supplier evaluation process to verify compliance with internal requirements.
• Supervise Receiving and Final Inspection functions.
• Responsible for Document Control activities (MasterControl) including control/route of label/document reviews/change notices, maintenance of device history records, and compliance with record retention.

Waltham, MA, US

• Manage Quality Assurance staff of 6 to ensure customer expectations are met in regard to quality of Class 1 Medical Devices. Ensure regulatory compliance for global product distribution.
• Responsible for Regulatory compliance with global regulations relating to Class I Medical Devices worldwide.
• Recall and MDR coordinator for the site
• Implemented ISO13485:2003 and obtained initial registration.
• Lead and maintain Internal Audit program to verify compliance with 21CFR 820, ISO 9001, and ISO 13485
• Supervise Quality Assurance Inspectors in all functions, finished goods/incoming materials inspections, maintaining label reviews, etc. Developed more robust inspection criteria with the addition of quality inspection.

Wixom, Michigan, US

• Ensure Regulatory compliance in pharmaceutical manufacturing processes for contract manufacturing company.
• Develop, maintain, and manage cGMP Quality Systems compliant to 21CFR 210 and 211.
• Performed quality release of materials for cGMP manufacture and of finished goods to clients for clinical trials.
• Provide detailed review of and approval for certificates of analysis for materials and client clinical trial materials.

• Manage MSDC GMP, GLP, and GCP quality systems
• Develop, maintain and manage MSDC SOPs
• Manage corporate archive in SpringCM for Discovery, Development and Operations for MSDC
• Manage MSDC paper archive system
• Develop and manage off-site storage of MSDC documents
• Assist in IND amendment preparation and review

Ensure Regulatory compliance of Pharmaceutical and Class I Medical Devices.Team Leader of Internal Audit program to include ISO 13485 and 9001 compliance, 21 CFR parts 210, 211, and 820 in addition to other regulatory body requirementsTeam Leader in development and implementation of Supplier Management program.Key team member during all on-site audits.

Waltham, MA, US

Ensure Regulatory compliance of Class I Medical Devices.Authored 4 key Quality Systems SOPs assuring regulatory compliance, implementing change and ensuring quality product to the end user.Successfully developed and implemented a system for records review prior to product release to market assuring regulatory complianceKey team member during ISO 13485.

Manage office of 45 Emergency Room Physicians and work with the President and Board Members to keep everything running smoothly.Manage President and Board Members meeting schedulesMedical Billing for "uncollectable" accountsPhysician RecruiterSuccessfully developed and implemented all marketing materialAttended "Resident Physician".

Bachelor, Professional Business

Associates Degree, Applied Science, Accounting

Bachelor'S Degree, Accounting And Business/Management