QA Inspector 1 - 2nd Shift at Dexcom

Posted in General Business 8 days ago.

Type: Full-Time
Location: San Diego, California





Job Description:

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.

Summary:

Performs necessary duties to evaluate assemblies and finished products to ensure conformance to drawing requirements, specifications and approved procedures. This position is responsible for ensuring that good manufacturing practices and good documentation practices are maintained in manufacturing, the coordination of the non-conforming materials process, and the review of electronic and paper Lot History Records.

PLEASE NOTE: This position schedule will be Mon-Tues / alternate Wednesday from 4:00pm to 2:30am

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 and 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 (GMP).

  • 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.

  • Review shipping documentation to assure accurate order shipment.

  • Works closely with Research & Development, Regulatory Affairs, Clinical, and Manufacturing groups.

  • 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 experience working with the following; Agile, Oracle and/or Camstar software programs.

Experience and Education Requirements:

  • Typically requires 0-2 years of related experience and a High school diploma/certificate or equivalent.
  • Prefers 1-2 years' experience in a quality assurance/quality control regulated environment; or equivalent combination of education, experience and/or training.

Travel Required:

  • 0 - 24%

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.

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.