Medical Device Document Control

Objective:

A long-term challenging position that uses my organizational, solution orientated, administrative skills with a company that provides advancement and learning opportunities.

Qualifications:

Regulatory Affairs and Quality Assurance Management

ISO and FDA audit preparation and progress compliance

EU Medical Device Regulation proficiency

Health and Safety and Environmental Compliance Management

Process Manufacturing and Discrete Manufacturing Administration

Manufacturing management and administrative supervision experience

Education:

Bachelor of Science: Biology, Portland State University, August 2005

Work Experience

RA / QA Manager InLight Medical 03-2019 to 10-2019 Addison, TX

Championed FDA Audit follow-up activities, including closing FDA 483 observation reports.

Developed new QMS structure, documents, and organizational matrix

Developed, published, and validated test protocols for Incoming Material testing, In-Process, and Final-Inspection test methods

Lead Flying Probe, ICT Testing, final packaging, post assembly, and full Functional Test

Developed and validated assurances of complete back end verification for manufacturing

Utilized Multimeter, Oscilloscope, Matlab, Minitab, and analytical methods in testing

Updated QMS management systems utilizing ETQ programs Verse and Reliance 2019

Crusaded external FDA audit compliance and regulatory action follow-up activity

Lead Quality Assurance and Quality Control Activities for Medical Device Manufacturing

Lead FDA Inspection Response project and FDA 483 Response Project

Lead Firm Initiated Supplier-Related Voluntary Recall Project and Coordinated with FDA Recall Enterprise System (RES)

Validated and Verified DMR and DHR for Medical Device Changes through Engineering Change Request (ECR)

Updated 510(k) for Polychromatic Low Light Therapy (PLLT) product with updated Gerber Files, PCBA design, and approved subcomponents

Updated Device Master Record (DMR) and Device History Records (DHR) with 510(k)

Developed and implemented supplier related, voluntary, firm-initiated product recall plan.

Achieved CAPA and Non-Conformance reporting requirements for 21 CFR 820 - 1300

Implemented process improvements for product analysis and employee quality training

Championed External Quality Audit observations and directed strategy planning

Directed Medical Device Complaint reports

Supported Internal Quality Audit (IQA) activities and with British Standards Institute

Document Analyst (CONTRACT) Flextronics 01-2018 to 12-2018 Irving, TX

Transitioning Quality Management Systems documents to update compliance with 21 CFR 11.

Updating Quality Management System documents for compliance with ISO 13485, 2016

Coordinate with Document Control Team document change activities from FlexQ Legacy to FlexQ Medical electronic document management system document updates.

Electronic Document Management System change from Flex Q Legacy to FlexQ Medical.

Developed, published, and validated test protocols for Incoming Material testing, In-Process, and Final-Inspection test methods

Lead Flying Probe, ICT Testing, final packaging, post assembly, and full Functional Test

Developed and validated assurances of complete back end verification for manufacturing

Utilized Multimeter, Oscilloscope, Matlab, Minitab, and analytical methods in testing

Maintained Medical Device Complaint reports

Training employees on specific relevant details for FlexQ Medical EDMS.

Updated design records for contract manufacturing and 510(k) approvals

Supported Internal Quality Audit (IQA) activities and with British Standards Institute.

Health and Safety and ISO Coordinator (CONTRACT) EXCO Extrusion Dies 08-2017 to 11-2017 Wylie, TX

Aligned Exco USA Health and Safety Programs with all governing authorities.

Managed the development and maintenance of health and safety programs

Coordinated training and maintain training records as required.

Directed the activities of the Safety committee.

Reported on health and safety issues relative to Exco management and employees.

Cultivated the development and maintenance of ISO programs.

Managed required machine calibrations and systems validations activities

Supported Internal Quality Audit (IQA) activities and with British Standards Institute

Apprised compliance activities with local fire department, Texas Commission of Environmental Quality, Environmental Protection Agency, and Occupational Safety and Health Association

Regulatory and Quality Assurance Associate (CONTRACT) Primal Health 10-2016 to 7-2017 Allen, TX

Responsible for Document Control document change control operations

Performing cGMP and environment for dietary supplement distribution company

Quality Assurance SOP writing and review

Assisting in document management procedure development

Distribution control for dietary supplements

Directed Dietary Supplement Customer Complaint reports

FTC and FDA document control for dietary supplement company

Advocated employee training protocols review and growth

Safeguarded FDA audit compliance for released dietary supplement products

Performing Document Control operational logistics

Featured review of Clinical Trials for Structure Function Claims

21 CFR 111 compliance for GMP practices for holding and distribution of dietary supplements and contract manufacturing of dietary supplements

Master Manufacturing Record review and Batch Production Record review of contract manufacturer’s dietary supplement manufacturing records

Medical Device Coordinator Nephron Pharmaceuticals 12-2015 to 07-2016 Columbia, SC

Directed Document Control document change control operations

Strategized FDA compliance in Medical Device Manufacturing

Developed new QMS

Developing medical device manufacturing and management

ISO 13485 compliance reviews, managed ISO auditor activity for product update

Cultivated personnel training paperwork maintenance

Involved document management maintenance

Redeveloped product design with product engineer for new 510(k) submission and approval

Developed, published, and validated test protocols for Incoming Material testing, In-Process, and Final-Inspection test methods

Lead Flying Probe, ICT Testing, final packaging, post assembly, and full Functional Test

Developed and validated assurances of complete back end verification for manufacturing

Utilized Multimeter, Oscilloscope, Matlab, Minitab, and analytical methods in testing

Submitted new 510(k) for successful product approval of Pocket Neb Nebulizer

Gained MicoVapor Devices’ 510(k) submission approval from FDA for Pocket Neb™

Developed design control and risk analysis reporting for nebulizer project

Applied Documentum and SharePoint document management

Validated and Verified Nebulizer Product for 510(k) submission project

Lead Assembly team

Lead 510(k) project and Nebulizer design project

Lead Quality Control and Quality Assurance of Nebulizer

Directed Medical Device Complaint reports

Lead weekly Quality Assurance meetings with owner, COO, Project Manager, and Sales

Developed SharePoint based document control infrastructure

Human Study Clinical Trials and reports for medical device approval

21 CFR 210 and 21 CFR 211 compliance for nebulized drug product

21 CFR 820 compliance for medical device manufacturing with nebulizer

QA Systems Specialist Oligos Etc., Inc. 08-2014 to 09-2015 Wilsonville, OR

Responsible for Document Control document change control operations

Performing cGMP and ASR product Quality Assurance document review operations

Assisting in document management procedure development

Developed new QMS

Reviewing and developing employee training protocols

Ensuring FDA compliance for released products

21 CFR 210 and 21 CFR 211 compliance for cGMP manufacturing processes with synthetic RNA and DNA manufacturing

Performing Document Control operational logistics

Directed Medical Device Complaint reports

Validated and Verified LIMS manufacturing program

Lead Quality Assurance Team

Lead Quality Control Team and Training

Documentum and SharePoint document management

Clinical Trials design and reporting for in-vitro diagnostic studies

21 CFR 820 compliance review, and process development for synthesized DNA/RNA used for in-vitro diagnostic (IVD) during weekly quality meetings with company owner and area supervisors

Supported Internal Quality Audit (IQA) activities and with American Society for Quality

AO Manufacturing Technician (CONTRACT) Genentech 12-2013 to 06-2014 Hillsboro, OR

Performing material handing for Aseptic Operations in the plant

Assisting in cleaning, set-up, sterilization, and disassembly of processing equipment

Performing preparation of sterile manufacturing components

SharePoint document management

21 CFR 211 and 21 CFR 210 compliance for manufactured pharmaceutical products

Performing cGMP documentation throughout manufacturing operations

Utilizing software applications (SAP and MES systems) throughout manufacturing processes

Environmental Safety Technician Acumed 01-2009 to 08-2013 Hillsboro, OR

Responsible for safety training classes and safety compliance in two manufacturing plants for all employees. Utilized MS Office, Windows XP/NT, PowerPoint and Presentation.

Initiated OSHA and EPA programs in the plants, and was able to get both facilities certified. Maintained the compliance with both plants.

Risk Control for orthopedic implant manufacturing.

21 CFR 820 compliance review with process and product engineers for medical device manufacturing and possible facility issues in root cause analysis and out of specification investigations and reviews

ISO 13485 compliance reviews with managers and ISO auditors annually

Was certified in a 40-hour Hazardous waste operations training, and implemented the plants hazardous waste management program and waste stream analysis.

Conducted forklift training classes, building management programs, and supervised contract labor for large projects, such as the Heating Ventilation Air Conditioning control, Fire Safety, and compliance inspection programs

Validated and Verified compliance programs for OSHA Safety and Environmental Compliance

Lead Team and Training for OSHA Safety and Environmental Compliance

Supported Internal Quality Audit (IQA) activities and with British Standards Institute

Material handling and disposal, including 55-gallon drums containing hazardous waste, and gas cylinders.

Annual 29 CFR 1910 compliance review for facilities and procedures with Quality Managers.

References:

Upon Request

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