Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class-while empowering the community to take control of diabetes. Dexcom reported full-year 2020 revenue of $1.9B, a growth of 30% versus 2019. Headquartered in San Diego, California, with additional offices in the U.S., Europe, and Asia Pacific, the company employs over 6,000 people worldwide.
Functional Description: Support Individual Contributor
Performs inspections, checks testing and sampling procedures for product manufacturing processes. Carries out packaging line, manufacturing inspections and sampling and testing of incoming components and raw materials to ensure that company standards are met. Monitors critical equipment and instrumentation. May draft procedures and assist with validating or troubleshooting testing methods, including assays. May apply approval or rejection labels to bulk raw materials once analytical data is evaluated.
Essential Duties & Responsibilities:
Performing in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GMP) for commercial and clinical product in a timely matter.
Maintain compliance with operating procedures and ensure training is completed prior to the operation of a task.
Ensure all documentation is legible, complete and correct per current Good Manufacturing Practices Inspect labeling for the finished product.
Understand and perform line clearance activities in manufacturing.
Perform in-process quality audits in manufacturing to assure compliance to manufacturing documentation and good documentation practices.
Assist with the NCMR process during manufacturing of commercial and clinical product.
Demonstrate good computer skills and perform computer operations to generate reports and graphs using Microsoft Word and Excel.
Perform in-process product inspection and testing for commercial and clinical product.
Must be able to distinguish between certain colors and pass an annual color vision test
Familiarize yourself with the manufacturing processes.
Review shipping documentation to assure accurate order shipment.
Works closely with Research & Development, Regulatory Affairs, Clinical, and Manufacturing groups.
Provide training for new employees
Takes on new challenges and expanding roles to assist with growing demands within different areas of the Quality Department.
Must have strong organization skills and attention to detail
Assumes and performs other duties as assigned.
Required Qualifications:
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ideally has past experience working with the following; Agile, Oracle and/or Camstar software programs.
Education Requirements:
High school diploma or general education degree (GED)
Minimum of 1 year experience in a quality assurance/quality control regulated environment; or equivalent combination of education, experience and/or training.
Travel Required:
Up to 25%
Functional Description
Performs inspections, checks testing and sampling procedures for product manufacturing processes. Carries out packaging line, manufacturing inspections and sampling and testing of incoming components and raw materials to ensure that company standards are met. Monitors critical equipment and instrumentation. May draft procedures and assist with validating or troubleshooting testing methods, including assays. May apply approval or rejection labels to bulk raw materials once analytical data is evaluated.
Functional/Business Knowledge
Basic understanding of general job aspects and limited understanding of the detailed aspects of the job.
Acquires job skills and learns the policies and procedures required to complete routine tasks.
Scope
Work at this level requires following standardized, routine methods, under immediate supervision.
Assignments are routine in nature and expectation is to follow pre-established guidelines and procedures.
Contacts are mostly within own team and immediate supervisor.
Judgement
Little responsibility for decisions as to method or selection of work.
Receives detailed instructions on routine work and new assignments.
Works under close supervision.
Management
N/A
Field Sales
N/A
Experience and Education
Typically requires 0-2 years of related experience and a High school diploma/certificate or equivalent.
Workplace Type
The Workplace Type for this role is Assigned Desk. Based on the nature of your role you will have an assigned desk or office located at a Dexcom site and should plan to be onsite approximately 4-5 days per week.
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.
