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Document Specialist V

OrangePeopleSunnyvale, CA🇺🇸United States

Why this role stands out

This hybrid role offers a fantastic opportunity to contribute to a leading social media company, managing critical documentation throughout the product lifecycle and developing expertise in regulated environments. If you are a detail-oriented and responsive individual, you will thrive in this position where you can make a significant impact and grow your career. Apply today to join an innovative team and take on exciting challenges!

Quick overview

SeniorityMid Senior
Work modeHybrid
LocationSunnyvale, CA, United States
Account ManagementClinical TrialsComplianceDocument Management

Job description

OP is currently looking for a Document Control Analyst who will support product programs by managing standard operating procedures, work instructions, forms, and all types of records from product concept through obsolescence for a leading social media company. 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 the Management System documentation and records through the product lifecycle.
  • Create and release documents based on input from quality and compliance teams to support the 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 by regulatory requirements.
  • Collaboratively communicate documentation and records requirements between Operations, Supply Chain, and Engineering to facilitate compliance with applicable medical device standards.
  • Maintenance of all applicable records, such as validation reports, test reports, exit reviews, and 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,s 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 in a regulated Medical Device environment.
  • Familiarity with Google Suite.
  • Familiarity with ISO 13485.
Benefits:
  • 401(k).
  • Dental Insurance.
  • Health insurance.
  • Vision insurance.
  • We are an equal opportunity employer and value diversity, equality, inclusion, and respect for people.
  • The salary will be determined based on several factors including, but not limited to, location, relevant education, qualifications, experience, technical skills, and business needs.
Additional Responsibilities:
  • Participate in OP monthly team meetings, and participate in team-building efforts.
  • Contribute to OP technical discussions, peer reviews, etc.
  • Contribute content and collaborate via the OP-Wiki/Knowledge Base.
  • Provide status reports to OP Account Management as requested.

About us:
OP is a technology consulting and solutions company, offering advisory and managed services, innovative platforms, and staffing solutions across a wide range of fields - including AI, cyber security, enterprise architecture, and beyond. Our most valuable asset is our people: dynamic, creative thinkers, who are passionate about doing quality work. As a member of the OP team, you will have access to industry-leading consulting practices, strategies & and technologies, innovative training & education. An ideal OP team member is a technology leader with a proven track record of technical excellence and a strong focus on process and methodology.

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