Documentation Specialist

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.

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