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Full-time Document Control Specialist/ Customer Service - Medical Device - Irvine, CA

at Walk Vascular in California

Essential Duties and Responsibilities:
Responsible for enterprise wide document management tasks and related services that allow clients to retrieve, capture, store, and destroy both physical and electronic documents:
• Administer the document lifecycle (author, approve publish, revise, retire, archive) Product Development, Procurement, R&D, manufacturing, and Quality documents.
• Prepare and utilize electronic templates.
• Scan and upload documents, assist in the updating of procedures, and typing documents (word, Excel, etc.) as required.
• Maintain the electronic master file as necessary.
• Prepare records for inactive storage according to the retention schedule; copy and scan documents as necessary for distribution and storage.
• Maintain Device Master Records and Device History Records as well as manage employee training records
• Manages document processes and systems to ensure control and availability of documentation to project personnel.
• Organize paper files with accuracy and speed.
• Review new and revised documentation for suitability and conformance to the quality system.
• Support Quality Management in performance of quality reviews and audits.
• Assist in training on documentation and record retention policies, records destruction, procedures and instructions to site personnel.
• Follows all safety guidelines.
• Maintain compliance with Quality System procedures and company policies
• Handle customer related- communications
• Perform other related duties as assigned by supervisor


Education and/or Work Experience Requirements:
• The candidate must be able to work in the U.S. The candidate must have a minimum of 2 years of continuous experience as a document control specialist in the pertinent fields
• Superb attention to detail
• Must have good oral and written communication skills
• Must be able to perform general purchasing functions
• Ability to describe processes that are shown to you
• Ability to follow directions
• Ability to type
• Must be proficient in using a Windows PC, Microsoft Office products
• Understanding of GMP and ISO quality systems
• High school diploma or GED required
• BS / BA degree preferred


Physical Requirements:

• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
• Must be able to talk, listen and speak clearly on telephone

Reference : Document Control Specialist/ Customer Service - Medical Device - Irvine, CA jobs


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Published at 14-03-2018
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