The Company

Dexcom Corporation (NASDAQ DXCM) 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 thousands of 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.

Location:

Address 232 S Dobson Mesa AZ, 85202

Position Summary:

In this role the individual is a contributor to the administration of the following Dexcom compliance functions:  Performing Cycle Counts, daily inventory of MRB material and participating in monthly finance observations.  Ensuring that product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.  Process and evaluate Non-Conforming Events (NCE), Nonconforming Material Reports, 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 international standards.

A professional that has knowledge in Manufacturing and Quality Management Systems with demonstrated experience in the application of Quality Assurance and Regulatory principles and policies, and project management skills.

Essential Duties and Responsibilities:

• Performing Cycle Counts, daily inventory of MRB material and participate in monthly finance observations. 
• Review nonconformance trending to identify need for corrective or preventive actions. 
• Review NCE and NCMR documentation for content and completion of required deliverables.  Provide guidance as necessary to ensure appropriate depth of investigation and action.
• Perform Internal Audits as a member of the Audit Team.  Participate in audit preparation, execution. 
• Compile and provide input on performance metrics for review with management.
• 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:

• 1-2 years previous experience, Manufacturing and/or Quality.
• Experience with Quality Management Systems, Cycle Counts, Nonconforming Material, Nonconforming Events.
• Good understanding of QMS as applied to medical devices.
• 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.
• Collaborative, able to work effectively with diverse functional groups.
• Experience can substitute for degree requirements.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required.

Preferred Qualifications:

• Associate degree (A. A.) or equivalent from two-year college or technical school, Bachelor’s degree or equivalent experience specialized in quality, regulatory affairs and/or business administration preferred.
• Minimum 1-3 years of quality or regulatory compliance experience in the medical device and/or pharmaceutical industries (other regulated industries may be considered).
• Or equivalent combination of education and experience.
• Quality System Auditor / Lead Auditor certification desired.

Functional Description: Professional Individual Contributor

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:

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• General application of concepts and principles.
• Demonstrates project management skills and successful track record of completion.
• Contributes to the development of new concepts, techniques, and standards.

Scope:

• Receives general oversight and guidance on approaches to compete project related tasks.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Develops solutions to a variety of problems.
• Builds productive internal/external working relationships.

Judgement:

• Exercises judgment within defined procedures and practices to determine appropriate action.
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

Experience and Education Requirements:

• Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience.

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. 

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 talentacquisition@dexcom.com. 

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 talentacquisition@dexcom.com. 

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided:  https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

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.
 

Salary: