The Company
Dexcom Corporation (NASDAQ DXCM; Market Cap $
- 3B) 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 nearly 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.
Summary:
Key contributor to the administration of the following DexCom compliance functions: Training, Corrective and Preventive Action (CAPA) and Internal/External Audits. Assist management to ensure that products, procedures, processes, contracts and services comply with applicable federal and state rules and regulations; as well as internal standards.
Responsible for operating the Quality Management System (QMS), writing procedures and processes to support the QMS development. Lead and undertake audits across all areas of the business as well as across the supply chain. Provide training and champion the Quality Management System. Work on many phases or sub-tasks of projects or entire projects of moderate complexity, with results impacting on project completion. Work under general supervision, reviewed at project milestones and/or on completion by Senior Management.
Essential Duties and Responsibilities:
Support internal and external audit activities as assigned (fulfill audit requests, review records for accuracy, scribe, etc.)
Compile and monitor quality metric and drive improvement actions for review with management.
Create training materials and execute training as necessary to communicate process requirements and provide guidance to the user community.
Identify training needs, evaluate training effectiveness, and drive improvement actions in order to enhance employee's quality awareness
Review CAPA documentation for content and completion of required deliverables. Provide guidance as necessary to ensure appropriate depth of investigation and corrective and/or preventive actions. Assess effectiveness of corrective and preventive actions. Prepare CAPA Review Board meeting agenda and minutes.
Conduct investigations into potential quality / compliance concerns. Keep management informed of issues.
Perform duties of Recall Coordinator in association with the Company's Corrections and Removals Policy.
Drive continuous improvement of processes and systems supporting the Company's compliance functions.
Stay current on applicable FDA, ISO and other applicable industry requirements. Monitor external publication sources for issues applicable to the Company.
Create or revise Standard Operating Procedures and Work Instructions governing the Company's compliance functions.
Perform other tasks as assigned to enable organizational and quality objectives to be met.
Required Qualifications:
Regulatory Knowledge: In-depth knowledge of regulations and standards such as ISO 13485, FDA 21 CFR Part 820, and other relevant guidelines.
Experience with implementing and maintaining quality management systems, particularly ISO 13485, which is specific to medical devices.
Experience managing projects, especially those related to quality improvement and regulatory compliance.
Strong analytical and problem-solving skills to identify issues and implement effective solutions.
Excellent written and verbal communication skills for reporting, documentation, and collaboration with cross-functional teams.
Education Requirements:
Associate's degree (A. A.) or equivalent from two-year college or technical school. Bachelor's degree (B. A.) in science, engineering, quality or other technical field from a four-year college or university preferred.
Minimum 3 years of relevant work experience in the medical device or pharmaceutical industries is often required. This can include roles in quality assurance, quality control, or regulatory affairs.
Travel Required:
0 20%
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.
