Technical Writer – Fremont

Organization: APN, Inc.
Contact Name: Abdul
Address: Brandin Ct, Fremont, CA 94538
Phone Number: 510-623-5049
Email Address: abdul@apninc.com
Web Site: www.apninc.com
Job Title: Technical Writer – CFR Part 820/ISO 13485 specifically documenting QMS documents
Job Duration: 6 months

Description
This position specifically is to help with merging of Quality System documentation between two sister sites that are being merged into one Quality System. Strong knowledge of ISO 13485 and 21 CFR Part 820 regulations will be of great benefit. This position will assist in the writing of the documents helping the working teams that will evaluate each site’s system.

Essential Functions
The following is meant to be a representative but not necessarily comprehensive summary of the duties and responsibilities for this position title:

  • Gather and research information for use in Quality System Updates
  • Assist in layout work
  • Write technical materials, such as SOPs, Work Instructions and Forms

Education and Experience

  • More than 5 years professional experience
  • Bachelor’s Degree or equivalent unless otherwise specified
  • Knowledge of Risk Documents such as DFMEA is preferred

Competencies

  • Strong knowledge of 21 CFR 21 Part 820 and ISO 13485
  • Highly organized and detail oriented with strong follow-up skills to manage large volumes of documentation
  • Ability to understand priorities
  • Excellent written and verbal communication skills
  • Accuracy in performing all functions of this position
  • Demonstrated proficiency in computer skills and with Microsoft Word, Excel, and Visio; and Adobe Acrobat.
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