Job Title: Technical Writer II

Duration: 12 Months

Location: Fremont, CA 94538

Shift: M-F 8am-5pm

Pay Rate: $40/hr

Job Responsibilities

• Work cross-functionally with other teams to create or revise documentation via the established document control process.

• Review and recommend revisions or changes in scope, format, and content to existing documentation. Maintain records and files of work and revisions.

• Work closely with Quality Assurance to ensure documentation implemented is compliant with regulatory requirements.

• Maintain strict compliance with Quality Management System requirements, ISO 13485, cGMP, QSR and other applicable regulations and/or standards.

• May be called upon the implement procedural changes supporting continuous improvement initiatives.

• Respond to Quality action related to CAPAs, SCARs or nonconformances.

• Proof-read and provide feedback on documentation prepared by other departments.

• Organize large amounts of technical information utilizing Advanced MS Word and Excel functions as well as manage many technical documents simultaneously.

Ideal Candidate Preferred Qualifications:

• Effective communication skills and the ability to collaborate with cross functional teams

• Education: B.S./B.A. in a scientific discipline (e.g. chemistry, chemical engineering, biology, bioengineering, etc.). Preference given to candidates with technical writing and scientific background.

• Experience (minimum): 2 - 5 years’ experience in a regulated environment (ISO 13485, FDA QSRs, GMP or IVDs)

• Ability to work independently with guidance from leadership, and as part of a team;

• Manage multiple activities, and adjust to changing priorities in a dynamic, FDA regulated environment.

• Strong attention to detail, and ability to understand technical terminology and complex processes.

• Experience in using an electronic Document Management System as a Technical Writer.