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Document Control And Training Specialist 3
4 weeks ago
The Company
Dexcom Corporation (NASDAQ DXCM) 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 thousands of 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.
As a Document Control and Training Specialist, you willbe responsible forsustaining the change control system and supporting all Document Control activitiesin accordance withDexcom's processes, 21 CFR Part 820 and ISO-13485. Competent with Microsoft office isa mustfor this position. Proficient in generating reportsin order tosupport other Quality Assurance systems. The ability to use critical thinking and resolve issues isrequired. A highly driven, detailed oriented person is essential for this position. Knowledge of electronic documentation systems isrequired.
Where you come in
You will manage the change control system. Review, route, assess training impact and release change orders.
You willassistin change control system software training and other training asrequired.
You will ensure projects are completed accurately and on time.
You will interact with internal and external customers.
You will support Quality in both external and internal audits.
You willmonitorthe status of in-process document changes to ensuretimelyrevisions.
You willassistcustomers with problem solving and offerpossible solutionsutilizingunderstanding of the job and applies knowledge and skills to complete a wide range of tasks.
You will scan,archiveand retrieve quality documents and records.
You will issue controlled and uncontrolled documents.
You willmaintainservice records of all departments.
You will prepare requests for reproduction of documents.
You willmaintainexternal standardsin accordance withstandard operating procedures.
You will support the development of documentation and configuration control procedures.
You will support the testing and improvement of the change control software and other supporting software.
You will generate Quality Assurance reports as needed.
What makes yousuccessful
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Minimum of4years 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 part820.
Must have the ability to applyacquiredknowledge of GDP and GMP to daily tasks.
Able to support rotating shift
Whatyou'llget:
A front row seat to life changing CGM technology.Learn about our brave #dexcomwarriors community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Experience and Education
Typically requires a minimum of4-6years of related experience and a school diploma/certificate or equivalent.
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 unsolicitedresumes/applications.
