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:
- Document control experience
- Familiarity with FDA and ISO 13485
- CFR part 11 experience
Nice-to-have Skills
- Familiarity with team center
- Basic knowledge of PLM processes
- 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.