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 2020 revenue of $1.9B, a growth of 30% versus 2019. Headquartered in San Diego, California, with additional offices in the U.S., Europe, and Asia Pacific, the company employs over 6,000 people worldwide.

Summary:

Key contributor to the administration of the following Dexcom compliance functions: DHF documentation review, 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 Verification and Validation protocols and executions for accuracy and completeness.
• Review DHF documentation for content and completion of required deliverables. Provide guidance as necessary to ensure appropriate content on documentation and verification of accuracy.
• Review and audit DHF documentation assuring traceability with objective evidence.
• 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:

• Minimum 4 years of Quality Assurance or Compliance experience in the medical device and/or pharmaceutical industries.
• Good understanding of QMS as applied to medical devices.
• Experience can substitute for degree requirements.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Preferred Qualifications:

• Direct experience with Nonconforming Material, CAPA, and Internal Auditing preferred.
• Quality System Auditor / Lead Auditor certification desired

Functional Description

Supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.

Functional/Business Knowledge

• A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
• Demonstrates further technical development and a track record of project success.
• Demonstrates an ability to coordinate multiple projects simultaneously.
• Considered a specialist in the field within the function.

Scope

• Assists in determining objectives of assignment. Plan schedules and arranges own activities in accomplishing objectives.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Networks with senior internal and external colleagues in own area of expertise.

Judgement

• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Normally receives little instruction on day-to-day work, general instructions on new assignments.

Management

• N/A

Field Sales

• N/A

Experience and Education

• Typically requires a Bachelors degree and a minimum of 5-8 years of related experience.

Workplace Type

• The Workplace Type for this role is Flex. Based on the nature of your position you will be working onsite approximately 2-3 days per week from collaborative space and hoteling desks at our Dexcom sites. You will need to be located within commuting distance (typically 75 miles/120km) of your assigned Dexcom site.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [email protected].

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at [email protected].

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.