- 180189 - Technical Writer II
- CA-Bay Area
- 6 Months
- Chipton-Ross is seeking a Technical Writer II for an opening in Fremont, CA.
The candidate will support R&D with primary responsibility for the hands-on management of documentation supporting software diagnostics product development and on-market product improvements. This candidate will work closely with cross-functional teams to write, edit, review and finalize technical documents required for software products which includes but not limited to documents involving design control deliverables, verification and validation protocols and reports, and other documents associated with the phase-gate development of new products and the transfer of products from R&D to production.
This technical writer role will be a trusted resource and a key core team member in a multi-functional, multi-site project team. This position will be responsible for developing the documents for the software application according to IEC 62304 and 21 CFR Part 11 environment.
* Follow design control for new software product development per FDA and international guidelines
* Build Design History File for new software product development
* Develop design control documentation, including Design and Development Plans, Development Reports, Test Method and Process Validation Protocols, FMEAs
* Manage document change control
* Develop Standard Operating Procedures
* Maintain integrity of documents to comply with and be incorporated into the company's quality procedures. High quality, well formatted, clear documentation following GDP (good documentation practices) is mandatory.
* Development of customer-facing documentation e.g. user guides, training manuals
* Solicit, align, and incorporate feedback from diverse stakeholders.
* Excellent verbal and written communication skills
* Skills in Microsoft Office
* Ability to work in a fast paced environment
* Ability to drive project progress per assigned task
* Must be highly collaborative, have the ability to work within a diverse team, and contribute to a supportive, positive work environment both within the team and in the greater site-wide community
* Knowledge of FDA regulations for software product development
* Translates software user needs pr
Accredited Bachelors in related field plus 5 year of experience
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.