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QA Engineer 2

Dexcom

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2-5 Years
a month ago
88 Viewed
4 Applied

Job Description

The Company

Dexcom Corporation (NASDAQ DXCM; Market Cap $44.3B) 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 nearly 10,000 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

The incumbent is responsible for performing all of the duties of a Supplier Quality Engineer II, as stated in this job description. Performs tasks with moderate oversight from the manager and/or designated senior level supplier QEs. Will assist senior quality engineers in the performance of their duties and will support, evaluate, revise, and implement specific aspects of the quality system, as assigned. The incumbent will be systematic, highly organized and articulate, and work well in a team environment. Job tasks require interfacing with external suppliers, internal manufacturing, engineering, regulatory, quality, materials, and operations personnel, and senior management. Will provide guidance and training to technical and administrative personnel, and incoming new hires, as assigned. A positive attitude is important while working in a fast-paced manufacturing environment and dealing with shifting priorities.

Essential Duties And Responsibilities

  • Maintain the supplier quality management system according to written policies and procedures. Will provide input on compliance and continuous improvement of business processes.
  • Provide quality guidance to other departments.
  • Provide support in conducting supplier audits, monitor supplier performance, provide information for supplier program metrics and periodic reports, and assist in administration of the supplier corrective action system.
  • Ability to travel in the U.S. and internationally.
  • Transitions into an active participant to the Supplier Review Committee (SRC) meetings and ensures ongoing supplier program transparency and open communication between cross-functional departments.
  • Maintains the Supplier Audit Schedule and monitors compliance with this schedule, on an ongoing basis.
  • May attend and support internal audits by regulatory and other outside agencies.
  • Transitions to establishing and maintaining supplier Quality Agreements, where needed, and any joint periodic supplier business reviews.
  • Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreement.
  • May work as a member of the design team, as required. Some type of activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
  • Have knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics; utilizing these techniques as appropriate per Dexcom and/or industry recognized standards.
  • Provides training and guidance to lower level quality engineers and new hires
  • Takes the initiative to suggest systems and process improvements that: increase product safety; increase product consistency and conformance to requirements; improve production efficiency and communication; reduce operating and scrap costs.
  • Reads and understands specifications and inspection criteria.
  • Reads schematics and mechanical drawings and provides input into revisions as needed.
  • Works and communicates effectively and professionally in a team environment with minimal supervision.
  • Applies proficient computer skills in the use of Microsoft Office and database applications (such as Oracle and Agile).
  • Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
  • Possess a basic understanding of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards including ISO 13485.
  • Previous training and/or certification to perform quality audits is highly desired.
  • Experience with supplier quality programs is highly desired.
  • 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 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.

Experience And Education Requirements

  • Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience or Master's degree and 0-2 years equivalent experience.

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.
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