Technical Writer III
Location: Fremont, CA 94538
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.
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/or Experience:
• More than 5 years professional experience.
• Bachelor's Degree or equivalent unless otherwise specified.
• Knowledge of Risk Documents such as DFMEA is preferred.
• 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 is required in performing all functions of this position.
• Must demonstrate proficiency in computer skills and Microsoft Word, Excel and Visio, and Adobe Acrobat.