Job Description:

About Dexcom:

Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.

Position Summary:

Key contributor to the administration of the following DexCom compliance functions: Corrective and Preventive Action (CAPA), 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 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.

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.


• Responsible for compiling metrics and data analysis in the following area:
  
  
  • Metrics for Management review
  
  
  • Metrics for partner meetings
  
  
  • Trending
  
  
  • Pareto analysis to drive projects / activities
  
  
  • Input to PFTs
  
  
  • Ad-hoc metrics to support investigations
  
  
  • Dashboards
  
  
  • E-GEMBA (align with Mesa and Malaysia mfg. sites)
  
  
  • Overall, improve data comprehension in order to move to predictive activities Use data to drive process improvements (reduced inspection time)
  
  
  
  


• Perform other tasks as assigned to enable organizational and quality objectives to be met.

Required Qualifications:

• Associate degree (A. A.) or equivalent from two-year college or technical school.


• Direct experience with Quality Management Systems, Nonconforming Material, Nonconforming Events, CAPA, and Internal Auditing.


• 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.


• Will analyze and extract data from systems for business decisions.

Preferred Qualifications:

• Bachelor's degree or equivalent experience specialized in quality, regulatory affairs and/or business administration preferred.


• Minimum 5 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.


• Previous use of Reliance electronic quality management system or equivalent.


• Quality System Auditor / Lead Auditor certification desired.

Travel Required:

• Up to 25%

Language Skills: Must be able to communicate effectively in English. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be required to perform the following Physical Activity: Standing, walking, sitting, using hands, handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear, taste or smell. May be required to lift 0 lbs. to over 100 lbs.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be exposed to the following environmental conditions: Wet or humid conditions, work near moving parts, work in high - precarious places, fumes or airborne particles, toxic or caustic chemicals, outdoor weather conditions, extreme heat (non-weather), extreme cold (non-weather), risk of electric shock, work with explosives, risk of radiation, vibration. The noise level in this work environment can range from quiet to very loud.

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.

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.

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.

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

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