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.
Assist with the maintenance of quality systems and facilitate continuous quality improvements. This position is responsible assisting with the maintenance and monitoring of a variety of cGMP documentation including complaint files, complaint processing system, Medical Device Reporting, corrective action and preventive actions (CAPA), and maintenance of other related quality system records as required.
Essential Duties and Responsibilities:
Review and evaluate complaints as per Standard Operating Procedure (SOP).
Assist with Medical Device Reporting.
Assist with reportable investigations
Document and maintain records of all complaint investigations in accordance with domestic and worldwide international regulations (e.g. 820, MDD, ISO, Canada, and other countries)
Complete all required customer complaint related documentation in an accurate, professional and timely manner.
Support internal, external, and third-party audits.
Perform routine complaint system data entry, documentation, and administrative tasks.
Assume and perform other duties as assigned.
Able to work flexible hours, including evenings, holidays and weekend. Overtime may be required.
This job has no supervisory responsibilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily to complete routine tasks. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
Preferred Associate’s degree (A.A.) from an accredited college or university; or one year related experience and/or training; or equivalent combination of education and experience.
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 with peers.
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 firstname.lastname@example.org .
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.