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. • Manage the Quality Department, including Quality Engineers, Quality Control and Document Control

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.• Collaborate with external Contract Development and Manufacturing Organizations to obtain necessary documentation for Technical File and DHF• Review and approve new and modified product labeling and promotional materials for compliance with product specifications and domestic and international labeling and promotional regulations.

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.• Responsible for Import / Export activities relating to manufactured and purchased products.• Responsible for customer complaints activities, investigations, and follow-up• Coordinate field corrective action/recalls related to complaints.• Coordinate CAPA root cause analysis investigations • Create / Report monthly Quality system metrics as part of Executive Management Review• Responsible for ensuring timely complaint investigations and providing feedback to customers.• Manage teams at multiple facilities. • Oversee global Quality System procedural harmonization.

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 tools, force gauge tester, optical comparator, and digital height gauge, to better perform duties. • Provide training to the organization on 21CFR 820, ISO 9001, and ISO 13485 requirements and proper procedures.• Implemented MasterControl Software for document management and training.• Supervise Document Control Specialist in all functions, control/route of label/document reviews/change notices, maintaining of device history records, compliance with record retention.• Supervise Label Control in all functions, managing artwork revisions, timeliness, quality. • Developed and implemented the Supplier Management program through the completion of supplier audits.• Record and investigate customer complaints/finished goods and raw materials non-conformities.• Maintain complaint and CAPA files. Coordinate field corrective action/recalls related to complaints.

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, manage the timely closure of any findings and building strong relationships with customersKey team member during ISO 13485 audit, successful completion of all action itemsTeam member for post FDA 483 response wrap-up

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 audit, successful completion of all action itemsKey team member in development and implementation of electronic complaint handling system and non-conforming material system. Which led to decreased time for closureSuccessfully implemented changes to enhance the Change Notice program to include New Product DevelopmentSuccessfully implemented changes to the Printed Material Review process to ensure proper review and sign off for Regulatory complianceKey team member of electronic MSDS system which reduced document storage and decreased response time to customersSpecial ProjectsKey team member in Corporate facility integration which added over 4000 finished goods to our portfolioWorked cross functionally with the Management team to redesign new product lineHelped all team members identify new parts for ease of production and shipmentKey team member of 2 separate New Product launches.Keeping teams on track and collecting necessary documentation for regulatory complianceKey team member of Rebrand project to implement our new corporate logo on all existing packaging for international labeling compliance

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" conferences with marketing materials to show what our company offersArranged all interviews, flight and hotel arrangements and area tours for prospective physiciansFacilitated keeping 45 physicians up to date with all of their credentials and licenses needed to practice medicineKey team member of scheduling process for 5 area Emergency DepartmentsAuthored multiple documents to track patient complaints and key information needed to keep company abreast of how the physicians are perceived

Bachelor, Professional Business

Associates Degree, Applied Science, Accounting

Bachelor'S Degree, Accounting And Business/Management