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.
Meet the team:
This role supports quality activities and projects to successfully meet department and corporate goals. Key contributor in support and collaboration for one or more areas of regulatory and IT compliance such as Quality Management System Regulation and Standards, System and functional risk assessments, validation plans and reports, Creating and maintaining Software Operating Procedures (SOPs), Process Instructions (PIs), and templates.
Where you come in:
You maintain and create process documentation
You support Quality audits as the System Matter Expert with the procedures
You as the system expert on system risks assessments
You communicate with small teams, peers, and management
You provide guidance and support defining the Quality Management System
You support new regulation gap analysis and updates to the Quality Management System
You support IT enterprise systems infrastructure, IT systems, implementation, deployment, post improvements, and maintenance
You ensure compliance with Domestic and International quality management systems
You support continuous improvement and review of the Quality Management System
You approve and review complex system test case scripts, automation scripts, approvals, and validation support
You provide guidance on data migration planning, scripting, and reporting.
You work closely with IT, Regulatory and Quality to ensure compliance with numerous agencies and requirements
You can assume job description reflects management’s assignment of essential functions, does not prescribe or restrict the tasks that may be assigned
What makes you successful:
You have experience in software non-medical device regulations (CFR Part 820, CSA, Validation for Non-Product Systems, ISO guidance and regulations)
You have direct experience with Quality Management Systems, Enterprise Computer Systems risk management and validations preferred
You can work collaboratively, able to work effectively with diverse functional groups
You must value and demonstrate diligence for compliance, as well as demonstrate technical competence and good judgement associated with each essential duty and responsibility
You have experience creating user needs and requirements
You must have intermediate to advanced experience with performing activities by creating and maintaining a Quality Management System
What you’ll get:
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.
Travel Required:
0-5%
Experience and Education Requirements:
Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience
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.
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