Offer summary

Qualifications:

Experience in software non-medical device regulations and Quality Management Systems., Intermediate to advanced experience in verification and validation activities., Ability to create user needs and requirements, and understand scripting languages., Collaborative mindset with the ability to work effectively with diverse functional groups..

Key responsabilities:

Maintain and map communication between systems and data sources.

Identify and assess system risks in large enterprise systems.

Support compliance with domestic and international quality management systems.

Create engineering deployment and network diagrams for systems and applications.

Job description

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.

Position Summary:

This position is highly technical requiring the candidate to have a intermediate to mastery understanding of how systems communicate, function and mitigating risks that may arise from changes to communication layers, data sources and/or failures. This position will support 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, including, but not limited:

Quality Management System Regulation and Standards
A beginner level understanding of artificial intelligence
Mapping and creating diagrams for enterprise systems.
System and functional risk assessments, validation plans and reports
Reviews, approvals, and assurance support for test scripts and case creation.
Data migration planning, scripting, and reporting
QMS IT and infrastructure guidance
Continuous Improvement
Additional quality responsibilities as assigned

Essential Duties and Responsibilities:

Maintain and map the communication between systems, data sources and other aspects of the enterprise software system.
Be the system expert on identifying and assessing system risks between large enterprise systems.
Communicate to small teams, peers, and management.
Provides guidance and support with technical solutions affecting and defining the Quality Management System.
Supports new regulation gap analysis and updates to the Quality Management System.
Support IT enterprise systems infrastructure, complex IT systems, implementation, deployment, post improvements, and maintenance.
Ensure compliance for Domestic and International quality management systems.
Supports continuous improvement and review of the Quality Management System.
Approves and reviews complex system test case scripts, automation scripts, approvals, and validation support.
Create engineering deployment and network diagrams for the system and applications.
Provides guidance on data migration planning, scripting, and reporting.
Works closely with IT and Quality to ensure compliance with numerous agencies and requirements
This job description reflects management’s assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.

Required Qualifications:

Experience in software non medical device regulations (CFR Part 820, CSA, Validation for Non Product Systems, ISO guidance and regulations)
Direct experience with Quality Management Systems, Enterprise Computer Systems risk management and validations preferred.
Collaborative, able to work effectively with diverse functional groups.
To perform this job successfully, an individual must value and demonstrate diligence for compliance, as well as demonstrate technical competence and good judgement associated with each essential duty and responsibility.
Experience creating user needs and requirements.
Experience understanding and reading, at a minimum one scripting language.
Must have an intermediate to advanced experience with performing verification and validation activities.
Experience creating and understanding workflow and deployment diagrams.
Experience working in a Quality capacity on large multi-layered Enterprise level systems.

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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