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Technical Writer - Manufacturing (ISO 13485)
Technical Writer - Manufacturing (ISO 13485)Glidewell • Irvine, California
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Technical Writer - Manufacturing (ISO 13485)

Technical Writer - Manufacturing (ISO 13485)

Glidewell • Irvine, California
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Description

Position at Prismatik Essential Functions :

  • Delivers high quality documentation and in-product text updates.
  • Generates protocols, technical reports, test methods, manufacturing instructions, project planning documents, and labeling documents.
  • Creates, updates, and maintains design history files, manufacturing bill of materials (BOM), routers procedures, bill of materials, travelers, and technical submission files.
  • Revises instructions for use (IFUs), files, manuals, brochures, and other documentation for updated or changed product information and procedures.
  • Analyzes technical documents meticulously to identify changes.
  • Submits copies to management for feedback.
  • Drafts and documents procedures and technical documentation from established notes, demonstrations, observations, and photographs.
  • Proofreads documents to ensure clarity, proper grammar, and spelling. Conforms to departmental style guidelines and ensures documentation meets the needs of the business and the audience.
  • Collaborates with internal team stakeholders to ensure alignment and execution of priorities. Participates in internal team discussions for ongoing feature work.
  • Coordinates with regulatory team on technical file submissions and approval process.
  • Coordinates, validates, and assists with documenting test results.
  • Utilizes document control system software.
  • Performs and / or supports internal and / or external audits as required.
  • Performs other related duties and projects as business needs require at direction of management.

Education and Experience :

  • Minimum three (3) years of direct documentation experience in manufacturing or related industry.
  • Experience in working in dental or medical device industry as a technical writer.
  • Experience with the use of electronic document control systems such as ETQ or CatsWeb, a plus.
  • Knowledge of 21 Code of Federal Regulations (CFR) 820 a plus.
  • Experience working in a Food & Drug Administration (FDA) regulated industry, a plus.
  • Experience with industry standards such as American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI) and International Organization for Standardization (ISO) a plus.
  • Pay Range : $28.50 to $36.00 / hr

    Exact compensation may vary based on skills and experience.

    Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!

    In addition are the following generous employee benefits : Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical / wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!

    Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at recruitment@glidewelldental.com. Please indicate the specifics of the assistance needed.

    Note to Current employees : Please apply through Employee Transfer Application to complete the transfer request form.

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