Dexcom

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

Meet the team:

This position will support quality activities and projects to successfully meet department and corporate goals. This position will require a mastery of understanding, interpreting, and implementing FDA and international regulations and using the guidance to create and maintain department procedures. Key contributor in authoring and leading the development life cycle of a project. Support and collaboration for one or more areas of business support software, and IT compliance, including, but not limited to:

• Maintaining the Quality Management System, FDA, and International Regulation and Standards
• Providing expert guidance to teams working within an FDA-regulated environment
• Mapping and creating diagrams for enterprise systems.
• Creating system and functional risk assessments, requirement documentation, validation plans, and reports.
• Supporting software development project teams.
• Continuous Improvement.
• Additional quality responsibilities as assigned.
• Have a mastery level understanding of the Software Development Life Cycle (SDLC)

Where you come in:

• You will maintain the Quality Management System and evaluate software and business processes to comply with existing and new FDA and International regulations.
• You will lead a project’s software development lifecycle as the Quality Lead.
• You will author documentation and provide guidance throughout the entire Software Development Life Cycle (GxP, Part 11, Requirements, Validation, and Summary documentation).
• You will provide mastery guidance on the proper use of wording for a requirement and provide test guidance on its testability.
• You will have the ability to understand large enterprise systems and experience working as a Quality Engineer with large enterprise software systems such as (SAP, Cloud PLM, Oracle, Camstar, etc.)

Communicate with teams, and provide quality guidance on a project team.

• You will able to learn technical jargon quickly and communicate with software engineers and IT.
• You will communicate to small teams, peers, and management.
• You will provide guidance and support with Quality solutions affecting and defining the Quality Management System.
• You will support new regulation gap analysis and updates to the Quality Management System.
• You will support IT enterprise systems infrastructure, complex IT systems, implementation, deployment, post-improvements, and maintenance.
• You will ensure compliance with Domestic and International quality management systems.
• You will support continuous improvement and review of the Quality Management System.
• You will create and approve complex system test case scripts, automation scripts, approvals, and validation support.
• You will create engineering deployment and network diagrams for the system and applications.
• You will provide guidance on data migration planning, scripting, and reporting.
• You will work closely with IT and Quality to ensure compliance with numerous agencies and requirements

What makes you successful:

• Your 5 – 7 years of experience working within a regulated environment as a Software Quality Assurance Lead Engineer or Manager.
• Your experience in Non-Medical Business Support Software Systems Regulations
• Your experience creating processes using FDA General Principles of Software Validation - Final Guidance for Software Validation
• Your xperience creating processes using FDA Computer Software Assurance for Production and Quality System Software (CSA).
• Must be able to use company-recognized regulations to guide teams.
• To succeed in this position, a candidate must quickly adapt and learn how the company does business and supports its goals.
• Your direct experience with Quality Management Systems, Enterprise Computer Systems risk management, and validations preferred.
• Must be able to present to small teams.
• Collaborative, able to work effectively with diverse functional groups.
• To perform this job successfully, an individual must value and demonstrate diligence for compliance, technical competence, and sound judgment associated with each essential duty and responsibility.
• Must have advanced experience with performing verification and validation activities.
• Your experience understanding workflow and deployment diagrams.
• Your experience working in a Quality capacity on large multi-layered Enterprise level systems.

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.

#LI-Hybrid

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.