Quality Support 2 at Dexcom in San Diego, California

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:

Performs necessary duties to assist and coordinate the electronic and physical control of nonconforming material, to ensure conformance to Quality Management System requirements, and applicable regulations. This position is responsible for ensuring that good manufacturing practices and good documentation practices are maintained in Non-Conforming Material Reports (NCMR), the coordination of the non-conforming materials process, and the review of electronic records.

Essential Duties and Responsibilities:

• Physical identification and verification of parts or finished goods under NCMR.


• Perform cycle counts in Material Review Board (MRB) locations to assure accurate accounting of products and good documentation practices.


• Perform material handling activities necessary to identify and control inventory of NCMR materials.


• Perform in-process and final electronic review of documents for accurate format, signatures, dating in accordance with Good Documentation Practices (GDP's) for commercial and clinical NCMR records in a timely matter via Reliance Software NCMR module.


• Ensure all documentation is legible, complete and correct per current Good Documentation Practices (GDP's).


• Maintain compliance with operating procedures and ensure training is completed prior to the operation of a task.


• Complete and review electronic transactions in Oracle to ensure electronic holds are adequately in place for material under NCMR.


• Work closely with Quality Engineering, Research & Development, Regulatory Affairs, Clinical, and Manufacturing groups.


• Support internal, external, and third-party audits when needed.


• Able to work flexible hours, including evenings, holidays, and weekends. Overtime may be required.


• Assumes and performs other duties as assigned.

Required Qualifications:

• Must be able to organize documentation and file documents


• Must have strong organization skills and attention to detail


• Ability to use a pallet jack.


• Understand shipping and receiving documentation.


• Mid-level computer skills, perform computer operations to read reports and graphs using Oracle, Microsoft Word and/or Excel.


• 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:

• License and ability to operate a forklift (Preferred).


• High school diploma


• Experience with the use of Excel spreadsheets and reports.


• Experience with Oracle transactions for material control and inventory management.


• Knowledge of document control system such as Agile (Preferred)..


• Experience in the Quality Assurance Department in a Medical Device Company


• 1-2 years of experience in a quality assurance/quality control regulated environment; or equivalent combination of education, experience and/or training.

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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