Document Control Analyst (Sunnyvale, CA)

Our Customer’s mission is to give people the power to build community and bring the world closer together. Through their family of apps and services, they are building a different kind of company that connects billions of people around the world, gives them ways to share what matters most to them, and helps bring people closer together.

Our Customer is seeking a skilled and knowledgeable contract Document Control Analyst to support product programs by managing Standard Operating Procedures, Work Instructions, Forms, and all types of Records from product concept through obsolescence. The Document Control Analyst has knowledge and experience working in regulated environments (i.e. ISO 13485) and sufficient knowledge and experience to be able to operate with minimal supervision. You are flexible, responsive, detail oriented, hands-on and able to manage competing demands.

This role is onsite in Sunnyvale, CA.

Responsibilities

• Support 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
  
  

Skills And 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
• CFR part 11 experience
• Experience working on a regulated Medical Device environment
• Familiarity with Google Suite
• Familiarity with ISO 13485
• Familiarity with team center preferred
• Basic knowledge of PLM processes preferred
• Experience working in a regulated med device environment preferred
  
  

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements)

• Health Benefits: Medical, Dental, Vision, 401k, FSA.
• Accrued PTO: Up to 15 days per 12 months on assignment
  
  

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.