Job Title: Document Specialist V (Document Control)
Location: Sunnyvale, CA (Onsite)
Duration: 12 Months of contract role
Pay Rate: $50-$58/hr on W2 without benefits (Open for further discussion)
Employment Type: W2
Document Specialist
Summary
The Document Control Analyst will 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.
Responsibilities:
Support client 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
IMPORTANT NOTICE: For California Applicants-
"Pursuant to the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Los Angeles Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance, qualified applicants will be considered for assignment with arrest and conviction records. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, meet client expectations, standards, and accompanying requirements, and safeguard business operations and company reputation."
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .
US Tech Solutions is 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, disability, or status as a protected veteran.
Recruiter: Devyani
Email Address:
Internal job id: 25-35875