Document Control Specialist 3 (Fixed Shift Pattern)
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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. 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. 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. The opportunity to improve health on a global scale stands before us.
Meet the Team
Are you looking to leverage your experience to be part of something big and help people take control of their health? Do you enjoy building and managing relationships to understand business needs, and then creating and implementing solutions to meet those needs? Do you want to be part of a high-performing team dedicated to doing the right thing? If so, we have an opening for you!
Overview
As a Document Control Specialist, you will sustain the change control system and support all Document Control activities in accordance with Dexcom’s processes, 21 CFR Part 820 and ISO-13485. Competence with Microsoft Office is essential. Proficiency in generating reports to support other Quality Assurance systems is required. Strong critical thinking, problem solving, and attention to detail are essential. Knowledge of electronic documentation systems is required.
Responsibilities
* Manage the change control system. Review, route and release change orders.
* Assist in change control system software training and other training as required.
* Ensure projects are completed accurately and on time.
* Interact with internal and external customers.
* Support Quality in both external and internal audits.
* Monitor the status of in-process document changes to ensure timely revisions.
* Assist customers with problem solving and offer possible solutions using knowledge of the job and skills to complete tasks.
* Scan, archive and retrieve quality documents and records.
* Issue 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.
What Makes You Successful
* You will have a minimum Level 6 in Quality or a related discipline.
* Minimum of 4 years related experience and/or training; or equivalent combination of education and experience.
* Ability to initiate process improvements.
* 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.
* Ability to apply Knowledge of GDP and GMP to daily tasks.
What You’ll Get
* A front row seat to life changing CGM technology. Learn about our community of Dexcom engineers and ambassadors.
* 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.
Note: This job description contains information about the role and expectations. Dexcom is not accepting unsolicited resumes or applications from staffing agencies for this requisition.
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