Technical Writer - design control standards, IVD in Santa Clara, CA at Apex Life Sciences

Date Posted: 10/12/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a Technical Writer who works closely with internal and global partners to write, edit, and publish internal documentation. 

RESPONSIBILITIES:

  • Works closely with cross functional project teams and other technical writers for writing projects and conducts formal review meetings, tracks project status, and resolves any communication barriers
  • Facilitates the timely development, change, review and approval of documentation.
  • Designs, develops, tests, and maintains documentation within established schedule and budget targets.
  • Creates, writes and edits high quality text using corporate and department style guidelines.
  • Assists in ancillary services and interdepartmental activities or applications required for publication, preparation, storage and delivery of documentation.
  • Participates on teams to drive organizational adoption of new tools and processes for content creation and management.
  • Develops and revises Quality System documents, such Guidance Documents, Work Instructions, and Templates to drive consistency and quality of content in user documentation.
  • Develops and revises Engineering documents, such Verification Plans, Test Cases, Test Reports, Work Instructions, and Templates to drive consistency and quality of content in documentation.
  • Communicates effectively with interdepartmental teams and external vendors/ customers during activities such as the design transfer and production.
  • Maintains established metrics to monitor department activities and performance measures.


QUALIFICATIONS:

  • Bachelor's degree in a scientific discipline, business administration, technical writing, or other related technical field required. Masters degree preferred.
  • 5+ years experience related to the medical device, software, pharmaceutical, or biotechnology industry required
  • Knowledge of current US and International regulations as it pertains to documentation (e.g., FDA, ISO, IVDD and 21 CFR Part -11), and control of electronic records preferred.
  • Demonstrable record of working on project teams while working on multiple projects.
  • Experience with mentoring other technical writers preferred.
  • Knowledge of medical device, software, pharmaceutical, or biotechnology industry preferred

***For immediate consideration, please email your updated resume to bfreeman@apexlifesciences.com with 'Technical Writer CA' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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