Hiring Document Control Specialist
Location Sunnyvale, CA
Onsite
Description:
Looking for a Document Control Specialist to work with multiple cross functional teams such as manufacturing, master data, engineering, quality, planning, logistics to ensure compliance with regulatory requirements and manage document life cycle in the quality management system including language translations to meet program objectives.
Responsibilities:
Coordinate with the team to identify the documents that had to be updated or created for deployment per program design changes.
Maintain a detailed list of ECOs, Curriculum and Documents (New document, Up-rev, Parallel document)
Assist teams with compiling documents and completion of documents weekly, follow up on action items through closure.
Conduct a weekly review of document life cycle workflow status in the QMS system Submitted, Pending Approval, Released, implemented.
Work with DRIs, tech writers, other doc control specialists, language translators, reviewers and approvers for timely approvals / closure to meet the due dates
Coordinate documentation and Engineering Change Orders (ECOs) related to major design reviews.
Create company curriculum ID s and drive the team to identify on the job training documents and training documents and ensure that the required process is followed to release documents.
Act as a liaison to report on the QMS document creation, present weekly status to the program leadership team and escalate issues as required.
Qualifications
5 years of experience in document control and life cycle management system (Agile), preferably in a regulated global manufacturing or engineering environment
Prior experience with writing the Standard Operating Procedures, Department Operating Procedures, Work Instructions
Excellent written and verbal communication, organization, project management and problem-solving skills
High attention to detail and ability to follow strict procedures
Assertive, outgoing personality with an ability to work collaboratively within a cross functional team
Skilled in the use of Microsoft PowerPoint, Microsoft Excel, Microsoft Word
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