Russell Tobin & Associates is seeking a Senior Document Control Specialist/Analyst V to work for one of our top airline clients. This role is working onsite in Sunnyvale. This role is responsible for supporting product programs by managing Standard Operating Procedures, Work Instructions, Forms, and all types of Records from product concept through obsolescence. The candidate must have knowledge and experience working in a regulated medical device environment.
Pay: $116 - 122 per hour on W2
Duration: 12 month - contract with possible extensions or FTE role
Schedule: Monday - Friday 40 hours per week
Location: Onsite in Sunnyvale, CA
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Top Skills
- 5+ years of related experience in a high-tech, fast-paced, consumer electronics environment managing medical device Quality Management System documentation and resulting records
- Experience with Teamcenter or related PLM/Document Management systems - crucial
- Experience working in a regulated med device environment
- Basic knowledge of PLM processes
- Familiarity with FDA and ISO 13485
- CFR part 11 experience
- Familiarity with Google Suite
What You Will Do
- Support Reality Labs Quality Management System documentation and records through the product lifecycle
- Create and release documents based on input from quality and compliance teams to support new product introduction, production product releases and clinical trials and FDA submission
- Ensure documentation and data related to the requirements of the Quality System are controlled in a manner that ensures integrity and accessibility
- Ensure document control activities such as document management, version control, distribution and reporting management are executed in a timely fashion and in accordance with regulatory requirements
- Collaboratively communicate documentation and records requirements between Operations, Supply Chain and Engineering to facilitate compliance to applicable medical devices standards
- Maintenance of all applicable records such as validation reports, test reports, exit reviews, test results, as defined by applicable regulations and standards
- Support audits for licensure and accreditation documents submission
- Support the maintenance of documents resulting from periodic document review
- Manage and organize complex projects and priorities, solve problems that impact release progress and provide detailed information to cross-functional teams
Must be authorized to work in the United States
Why Join?
This role offers the chance to impact financial performance, gain exposure to strong leadership principles, and grow professionally-all with competitive pay and potential for long-term engagement.
Russell Tobin offers eligible employees comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors