About Dexcom:

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.

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.

Essential Duties & 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 a member of the Audit Team. Participate in audit preparation, execution. Track completion of audit responses and verify effectiveness of actions taken.


• Compile CAPA and Internal Audit performance metrics for review with management.


• Assist with 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:

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


• 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.

Preferred Qualifications:

• Some experience in 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.

Experience and Education Requirements:

• Typically requires a Bachelor's degree and 0-2 years previous experience.

Travel Required :

• Up to 25%

Functional/Business Knowledge:

• Learns to use professional concepts and skills.


• Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts, and principles. Learns to use professional concepts and skills.


• Applies company policies and procedures to resolve routine issues.

Scope:

• Works on problems of limited scope and complexity.


• Works under only general supervision. Work is reviewed for soundness of judgment and overall accuracy. Receives general oversight and guidance on approaches for project related tasks.


• Builds stable working relationships internally.

Judgement:

• Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.


• Normally receives detailed instructions on all work and work output it closely supervised.

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.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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 Talent Acquisition at talentacquisition@dexcom.com.

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.