The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Summary:
As a member of the QA Lot Release team, the inspector is responsible to ensure the activities related to the inspection functions in a manner which meets company standards and methods as determined by quality assurance or other engineering departments.
Performs inspections, checks testing and sampling procedures for product manufacturing processes. Carries out packaging line, manufacturing inspections and sampling and testing of in-process and Lot Release to ensure that company standards are met. Monitors critical equipment and instrumentation. May apply approval or rejection labels to lot/product 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 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.
Initiate and 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
Familiarize yourself with the manufacturing processes.
Review shipping documentation to assure accurate order shipment.
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:
Typically requires a high school certificate (SPM) or Diploma in any field or equivalent with minimum 2 years of relevant industry experience and/or training.
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.
Experience using computer
Ability to understand and perform job per documents instructions in English
Good interpersonal and teamwork skills.
Must be able to flex schedule to work in different shifts to meet demand.
Preferred Qualifications:
Quality Assurance and/or QA/QC experience.
Min 2 years in the medical device industry or manufacturing industry previous experience.
Ideally has experience working with the following: Agile, Oracle and/or Camstar software programs.
Education Requirements:
High school certificate (SPM) or Diploma in any field or equivalent.
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 unsolicitedresumes/applications.
