Technical Writer Medical Device
Resume:
Summary
Highly organized and experienced Technical Writer / Technical Editor leverages background in quality system management and marketing / communications to create internal and user-facing support documentation for both technical and general audiences.
Specialize in writing standard operating procedures and work instructions. Skilled at analyzing and interpreting technical standards, guidance documents, international laws, and other governing directives, and putting them into practical use by incorporating their requirements into user friendly documentation necessary for an effective quality management system.
Overview of Skills and Qualifications
Excellent organizational and project management skills, and strong attention to detail, enable effective collaboration with cross functional teams to achieve company objectives.
Developed the documentation required to implement, maintain, and continually improve the quality management systems (QMS) of four (4) medical device manufacturing companies – Lancer Orthodontics, Orthodontic Design & Production, Inc., Surgistar, and Pacific Metrology.
Work regularly with subject matter experts (SMEs) across all levels to create, proofread, edit, approve, and maintain technical documents in support of top management objectives. These documents include:
Quality System Manuals
Post Market Surveillance Reports
Product Promotional Materials
Product Instructions for Use
Operating Procedures
Corrective Action Reports
Clinical Evaluation Reports
Risk Analysis Reports
Task-specific Work Instructions
Management Review Presentations
Biological Safety Reports
Forms, Logs, Spreadsheets
Professional Experience
August 2022 – Present – Part Time Consultant – Escondido, California
Worked with two (2) clients simultaneously (Fashionphile and Lancer Orthodontics) to develop, implement, and maintain the standard operating procedures, work instructions, and other documentation required for the operation and continual improvement of their quality management systems.
Specific services provided included Technical Writing, Editing, and Proofreading Establishing Documentation Structures CAPA Management (including customer complaints) Internal QMS Audits Employee Training.
Conducted research and gathered information from subject matter experts to create and update technical documentation such as standard operating procedures and work instructions.
November 2021 – August 2022 – Quality Manager – NEOTech, San Marcos, California
Reviewed and rewrote as required all QMS procedures and work instructions to more accurately describe current practices. This involved more than 45 QMS procedures and 50 work instructions.
Led the team that achieved Medical Device Single Audit Program (“MDSAP”) certification with zero nonconformities, thereby establishing compliance with the medical device manufacturing regulatory requirements of Australia, Brazil, Canada, Japan, and the United States, enabling product registration in those countries.
Promoted a company-wide, quality-focused environment dedicated to maintaining and improving the quality management system. Gathered and reported statistical data on the status of the quality management system to top management by leading management review meetings.
Jan. 2017 – Nov. 2021: Regulatory / MarCom Manager - Lancer Orthodontics, Carlsbad, Ca.
Led the international team (US and Mexico) that developed the documentation required to achieve MDSAP certification, thereby establishing compliance with the medical device manufacturing regulatory requirements of Canada and the United States.
Re-wrote each of the company 12 technical files for more effective compliance with the European Medical Device Directives (EU MDD). Technical file contents included risk management reports, clinical evaluation reports, biological safety reports, post market surveillance reports, product design information, product packaging and labeling information, and other applicable device information as required by the EU MDD.
As Marketing / Communications (MarCom) Manager, worked with graphic designers to create product-related user information, including instructions for use and copy for the company’s website, fliers, brochures, and catalogs.
Ensured that all product labeling met applicable regulatory requirements, including international Unique Device Identification (“UDI”) requirements.
Worked with subject matter experts (“SMEs”) across all levels to develop standard operating procedures (SOPs) and Work Instructions (WI) for each function within the company.
Managed the document control process, including version control, document approval, and distribution.
Maintained an organized and up-to-date library of technical documentation.
Nov. 2015 – July 2018 Regulatory Affairs Manager – Surgistar, Vista, California
(Worked simultaneously at Lancer Orthodontics and Surgistar January 2017 to July 2018)
Led the team that achieved MDSAP certification, thereby establishing compliance with the medical device manufacturing regulatory requirements of Australia, Brazil, Canada, Japan, and the United States, thereby enabling product registration in those countries.
Rewrote all company procedures and work instructions to accurately reflect current activities.
Rewrote all 4 company technical files for more effective compliance with EU MDD requirements.
Nov. 2002 – Nov. 2015 Regulatory Affairs Manager, Orthodontic Design & Production, Inc. (ODP), Vista, Ca.
Led the team that implemented the company’s QMS (the company previously had no QMS in place).
Achieved CE marking approval for EU Class 1 and EU Class IIa medical devices, enabling product entry into European markets.
Led the team that achieved certification to The Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations 2005/07 (JPAL), enabling market entry into Japan.
Led cross-functional team which integrated the quality management systems of two merged companies Orthodontic Design & Production Inc., and G&H Orthodontics) for the purpose of bringing the merged organizations under one notified body (BSI).
Achieved 510(k) premarket notification clearance for two FDA Class II medical devices (orthodontic ceramic brackets – K130446 and K132368).
As General Services Administration (GSA) proposal manager, was responsible for the award of a five-year contract as an approved supplier to the United States Government.
Used examples of effective QMS techniques to capture The World Trade Center San Diego North County International Trade Excellence Award (2010) and the World Trade Center San Diego International Business Leadership Award-Exporter of the Year (2011).
Education
B.A. communications: National University, San Diego, California.
A.S. computer electronics technology: Coleman University, San Diego, California (Magna cum Laude).
Additional Information
Adept at interpreting and implementing the requirements of the following standards:
FDA Code of Federal Regulations (CFR) Part 820: Quality System Regulation.
ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes.
ISO 9001:2015: Quality management systems – Requirements.
SOR 98-282: Health Canada, Statutory Orders and Regulations (SOR).
MHLW Ministerial Ordinance No. 169 (2004): The Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics.
Resolution RDC No. 185 of October 22, 2001: Brazilian Medical Device Regulations.
Australian regulatory guidelines for medical devices (ARGMD).
Veteran - United States Army (Honorable Discharge, Held Secret Clearance).
Proficient in Microsoft Office, SharePoint, and other relevant software applications.
Published, Award-Winning Author (Gangway, Regular Navy – Memoirs of Life and Humor in the United States Navy During the Cold War) Heritage Books, 2005. Awarded the “Silver Medal for Literary Excellence” by the Military Writers Society of America.
Consulting website: www.merrellandcompany.com (self-designed, written, and published).
Writing samples available upon request.
Excellent references available upon request.
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