Documentation Specialist Contract Engineer

Russell Tobin & Associates is currently seeking a Documentation Specialist to work for our client in the tech industry. Apply now for consideration!

W2 Contract: 12 Months

Location: Onsite- Sunnyvale, CA

Pay: $50-56.57/hour (DOE)

Primary Objectives

• 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 which 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
• Support the implementation of new eQMS
• End user support and problem resolution

Qualifications:

• 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
• Experience working on a regulated Medical Device environment
• Familiarity with Google Suite
• Familiarity with ISO 13485

Russell Tobin / Pride Global offers eligible employee’s 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.