Job Description

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. Summary: Key contributor to the administration of the following Dexcom compliance functions: Corrective and Preventive Action (CAPA) and Internal 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. Essential Duties and Responsibilities: 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. Review nonconformance trending to identify need for corrective or preventive actions. Perform Internal Audits as Lead Auditor or member of the Audit Team. Participate in audit preparation, execution and audit reporting. Track completion of audit responses and verify effectiveness of actions taken. Compile CAPA and Internal Audit performance metrics for review with management. Perform duties of Recall Coordinator in association with the Company\'s Corrections and Removals Policy. Create or revise Standard Operating Procedures and Work Instructions governing the Company\'s compliance functions. Assist management with 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 training materials and execute training as necessary to communicate process requirements and provide guidance to user community. Conduct investigations into potential quality / compliance concerns. Keep management informed of issues. Perform other tasks as assigned to enable organizational and quality objectives to be met. Required Qualifications: Direct experience with Nonconforming Material, CAPA, and Internal Auditing preferred. Good understanding of QMS as applied to medical devices. Experience can substitute for degree requirements. 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 4 years of Quality Assurance or Compliance experience in the medical device and/or pharmaceutical industries. 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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