About DexcomFounded 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:Position Summary:Supports quality activities and projects to successfully meet department and corporate goals. Key contributor in support and collaboration for one or more areas of regulatory compliance, including, but not limited:Quality Management System Regulation and StandardsAuditsContinuous ImprovementAdditional quality responsibilities as assigned.Where you come in:The Quality Compliance Specialist II coordinates the Global QMS Regulation assessments, supports Internal Audits process, and acts as a Quality Management System liaison. Key responsibilities include but are not limited to:You will coordinate assessments of new and revised regulations and guidance documentsYou will support quality compliance initiatives and providing technical guidance for new and sustaining product(s).You will support quality compliance and cross-functional continuous improvement initiatives.You will support internal and external audit activities as assigned (fulfill audit requests, review records for accuracy, scribe, etc.)You will support field action activities as assigned (review of responses, response data processing, etc.)What makes you successful:Your direct experience with Quality Management Systems, Change Control, Audits, CAPA.Your knowledgeable in ISO 13485:2016, ISO 14971, MDSAP regulations, EU MDR, and other regulations applicable to Medical Devices.Your collaborative, able to work effectively with diverse functional groups, able to multitask and adjust to change in prioritiesTo 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.Your ISO 19011 Training or Auditor certification preferredYour project management experience preferred.Typically requires a Bachelors degree and a minimum of 2-5 years of related experience or equivalent years of direct experience in Medical Device Industry.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-HybridTo 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 unsolicitedresumes/applications.
