Document Control Specialist
Proteus Digital Health - Hayward, CA

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Finding a good job is very good.

Finding a good job in a dynamic, growing company is great.

Finding a great job in a world-changing organization is an once-in-a-lifetime opportunity.

Welcome to Proteus Digital Health, which is pioneering a new category of products, services and data systems based on ingestible computing. Our core technology – the digital health feedback system – provides an unprecedented view into an individual’s personal health choices and physiologic response. This care-altering feedback system enables patients to better manage their health, allows more effective collaboration with caregivers and clinicians, all while enabling new information-based business models.

Think You Measure Up? What Amazon did with books, and Apple did with music, Proteus is poised to do with digital medicine. Come join our unique collection of innovative scientists, engineers, market makers, designers, doctors, developers, clinicians, and other digital health industry pioneers, and help us dramatically improve the lives of tens of millions across the globe.

We Are Seeking:

Job Title: Document Control Specialist

Department: Quality

The Document Control Specialist is responsible to maintain company quality system documentation through the Document Control system, in accordance with FDA QSR and ISO 13485 standards.

Responsibilities:
  • Review electronic Document Control submissions for accuracy and integrity, route documents for approval, and perform final release and distribution of effective documents

  • Maintain hard copy system of distribution and retrieval in Production work areas

  • Provide training for new personnel, including Document Control and Training modules

  • Maintain hard copy training records and electronic training record systems

  • Provide administrative support related to documentation and training system requirements

  • Participate in department decision making in relation to updating procedures and improving departmental processes

  • Inform management in a timely manner of compliance problems and project schedule delays

  • Perform other related duties and responsibilities to support Document Control and Quality as defined by management

Are You a Fit?
  • 4-6 years experience in Quality Assurance field with emphasis on medical devices

  • Proficiency in the use of MS Office, Word, Excel, Outlook

  • Database management experience desired

  • Ability to triage workload in a fast-paced high volume work environment

  • Strong organizational skills to manage daily tasks and routine assignments

  • Strong teamwork and communication skills – will involve interfacing and supporting various functional departments

  • Working knowledge of Document Control requirements according to FDA QSR and ISO13485

  • Must be self-motivated

Ready for the Ride of Your Life? We're looking forward to receiving your resume!

About Us: Proteus has received FDA market clearance in the U.S. and a CE mark in Europe for its wearable and ingestible sensor devices. Headquartered in Redwood City, Calif., Proteus is privately held and funded by Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic, Novartis, Otsuka, Oracle, ON Semiconductor and other investors. For more information please visit www.proteus.com.