Document Control And Training Specialist 2

Pulau Pinang, Malaysia

Job Description


:The CompanyDexcom Corporation (NASDAQ DXCM; Market Cap $44.3B) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we\'re just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we\'ve started: Improving human health.We are driven by nearly 10,000 ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We\'ve already changed millions of lives and we\'re ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We\'ll get there by constantly reinventing unique biosensing-technology experiences. Though we\'ve come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.Essential Duties and Responsibilities:

  • Manage the change control system (Cloud PLM); Review, route, assess training impact and release change orders.
  • Assist in Cloud PLM software training and other training as required.
  • Ensure projects are completed accurately and on time.
  • Able to interact with internal and external customers.
  • Support Quality in both external and internal audits.
  • Monitoring status of in-process document changes to ensure timely revisions.
  • Assist customers with problem solving and offer possible solutions utilizing understanding of the job and applies knowledge and skills to complete a wide range of tasks.
  • Scan, archive and retrieve quality documents and records.
  • Issues controlled and uncontrolled documents.
  • Maintain service records of all departments.
  • Prepare requests for reproduction of documents.
  • Maintain external standards in accordance with standard operating procedures.
  • Support the development of documentation and configuration control procedures.
  • Support the testing and improvement of the change control software and other supporting software.
  • Generate Quality Assurance reports as needed.
  • This position assumes and performs other duties as assigned.
  • Able to work in shift.
Required Qualifications:
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • Minimum of 2+ years related experience and/or training; or equivalent combination of education and experience
  • Proficient with Microsoft Office Suite
  • Ability to create reports in support of other Quality Assurance systems.
  • Ability to use critical thinking and resolve issues.
  • Knowledge of electronic documentation systems.
  • Good understanding of Document Control requirements and processes as outlined in ISO 13485 and 20 CFR part 820.
  • Must have the ability to apply acquired knowledge of GDP and GMP to daily tasks.
Preferred Qualifications: (Optional)
  • Experience with Cloud PLM Document Control system
Experience and Education Requirements:
  • Post Graduate Diploma/Professional Degree in Business Studies/Administration/Management, or equivalent.
Travel Required (select one, delete others):
  • Up to 25%
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

Dexcom

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Job Detail

  • Job Id
    JD1053073
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Pulau Pinang, Malaysia
  • Education
    Not mentioned