Job Description

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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\xe2\x80\x99s 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.

Essential Duties and Responsibilities:

• Act as subject matter expert to develop and support verification and validation activities for Equipment and Process (IQ/OQ/PQ/PPQ), Test Method Validations, Computer Software Assurance methodology and Validation Master Planning.
• Provide QA & QC requirements for IT & OT systems
• Provide guidance / expertise on GxP risk-assessment at system level, functionality level, and data element level
• Provide guidance / expertise on EU MDR as well as 21 CFR 820 & 21 CFR Part 11
• Actively participate as a core advisor to the IT/OT teams.
• Effectively communicates with broad Dexcom team and upper level management on project progress and challenges.
• Applies risk management, validation, sample size, and external standards review and implementation activities.
• Applies techniques like six sigma and Total Quality Management to improve Dexcom operations.
• Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples could include equipment, process, software and test method validation, auditing, calibrations, CAPA, customer complaint processing, document control, nonconforming materials, process controls, receiving inspection, training.
• Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
• Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
• Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab).
• Assumes and performs other duties as assigned.

Required Qualifications:

• Experience with validation of enterprise computer systems as used in pharmaceutical and/or medical device environments, such as Electronic Document Management Systems, Manufacturing Execution Systems, Enterprise Resource Planning Systems, Clinical Data Management Systems, and/or Laboratory Information Management Systems.
• Must have a thorough understanding of GxP-related business processes and Quality Systems, and FDA electronic records/signature requirements and computer validation expectations
• Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems)
• Experience with providing risk-based quality guidance for IT & OT systems, ideally with experience in med device / discrete manufacturing
• Knowledge and understanding of FDA Computer System Assurance (CSA) principles and methodology.
• Must be able to work independently to perform a project management role within cross-functional teams and with projects of varying degrees of complexity
• Excellent written and verbal communication skills, with hands-on experience creating CSV documentation
• Excellent organizational skills and attention to detail

Preferred Qualifications:

• Proven experience with all levels of SDLC artifacts for 21 CFR Part 11 impacted systems
• Proven expertise in delivering full cycle CSV programs to deliver 21 CFR Part 11 compliance across both IT systems and OT (Operations Technology) systems (such as MES, PLC)
• Proven expertise creating and executing Computer System Validation Plans & Protocols
• Proven skills in leading teams, and cross-functional collaboration
• Medical device or regulated industry experience strongly preferred.
• ASQ SQE (Software Quality Engineer) certification
• Expertise in 21 CFR Part 11
• Familiarity with 21 CFR 820 a plus
• Experienced in validating manufacturing automation solutions including MES, SCADA, PLC, Data Historians, EBR

Education/Experience Requirements:

• Bachelor\'s degree (B. S.) from four-year college or university
• Typically requires a minimum of 5 years of related experience with a Bachelor\xe2\x80\x99s degree; or 3 years and a Master\xe2\x80\x99s degree; or a PhD without experience; or equivalent work experience.
• 5 Years of direct experience in Validation of Manufacturing system

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.

Dexcom