Documentation Specialist Job at Russell Tobin, Sunnyvale, CA

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  • Russell Tobin
  • Sunnyvale, CA

Job Description

The Scientific Team at Russell Tobin & Associates is supporting a Leading Technology Company for hiring a " Documentation Specialist V "

Responsibilities:

  • Manage Quality Management System (QMS) documentation and records throughout the product lifecycle.
  • Create and release documents to support product introduction, production, clinical trials, and FDA submissions.
  • Ensure proper document control (management, version control, distribution) and compliance with regulations.
  • Collaborate with Operations, Supply Chain, and Engineering to ensure compliance with medical device standards.
  • Maintain records such as validation and test reports, exit reviews, and results.
  • Support audits for licensure and accreditation.
  • Manage complex projects, solve problems impacting release progress, and support cross-functional teams.
  • Help implement new eQMS and provide end-user support.

Qualifications:

  • 5+ years of experience in medical device QMS documentation, preferably in a fast-paced consumer electronics environment.
  • Experience with Teamcenter or similar PLM/Document Management systems.
  • Experience in a regulated Medical Device environment.
  • Familiarity with Google Suite and ISO 13485.

Must Have Skills:

  1. Document control experience
  2. Familiarity with FDA and ISO 13485
  3. CFR part 11 experience

Nice-to-have Skills

  1. Familiarity with team center
  2. Basic knowledge of PLM processes
  3. Experience working in a regulated med device environment

Additional Details:

Position Type: 12 months with possible extension/conversion

Pay range: $45/hr-$60/hr. on W2

Location: Sunnyvale, CA

Onsite position

Must be authorized to work in the United States.

APPLY NOW!

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