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 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:
Where you come in:
• You maintain the Quality Management System, FDA, and International Regulation and Standards.
• You provide expert guidance to teams working within an FDA-regulated environment.
• You map and create diagrams for enterprise systems.
• You create system and functional risk assessments, requirement documentation, validation plans, and reports.
• You support software development project teams.
• You drive continuous improvement.
• You handle additional quality responsibilities as assigned.
• You have a mastery-level understanding of the Software Development Life Cycle (SDLC).
• You maintain the Quality Management System and evaluate software and business processes to comply with existing and new FDA and International regulations.
• You lead a project’s software development lifecycle as the Quality Lead.
• You author documentation and provide guidance throughout the entire Software Development Life Cycle (GxP, Part 11, Requirements, Validation, and Summary documentation).
• You provide mastery guidance on the proper use of wording for a requirement and provide test guidance on its testability.
• You understand large enterprise systems and have experience working as a Quality Engineer with large enterprise software systems such as SAP, Cloud PLM, Oracle, Camstar, etc.
• You communicate with teams and provide quality guidance on a project team.
• You learn technical jargon quickly and communicate with software engineers and IT.
• You communicate with small teams, peers, and management.
• You provide guidance and support with Quality solutions affecting and defining the Quality Management System.
• You support new regulation gap analysis and updates to the Quality Management System.
• You support IT enterprise systems infrastructure, complex 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 create and approve complex system test case scripts, automation scripts, approvals, and validation support.
• You create engineering deployment and network diagrams for the system and applications.
• You provide guidance on data migration planning, scripting, and reporting.
• You work closely with IT and Quality to ensure compliance with numerous agencies and requirements.
• You understand that this job description reflects management’s assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.
What makes you successful:
• You must have 5-7 years of experience working within a regulated environment as a Software Quality Assurance Lead Engineer or Manager.
• You must have experience in Non-Medical Business Support Software Systems Regulations.
• You have experience creating processes using FDA General Principles of Software Validation - Final Guidance for Software Validation.
• You have experience creating processes using FDA Computer Software Assurance for Production and Quality System Software (CSA).
• You must be able to use company-recognized regulations to guide teams.
• You quickly adapt and learn how the company does business and supports its goals to succeed in this position.
• Your direct experience with Quality Management Systems, Enterprise Computer Systems risk management, and validations is preferred.
• You must be able to present to small teams.
• You are collaborative and able to work effectively with diverse functional groups.
• You value and demonstrate diligence for compliance, technical competence, and sound judgment associated with each essential duty and responsibility to perform this job successfully.
• You must have advanced experience with performing verification and validation activities.
• You have experience understanding workflow and deployment diagrams.
• You have 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.
Top Skills
What We Do
Dexcom Corporation 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 over 10,000 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
