Sr QA Engineer

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 the duties of a Senior Supplier Quality Engineer. Performs tasks with greater scope and minimal oversight from the Supervisor. May assist or supervise other Quality Engineers, technicians and/or administrative personnel in the performance of their duties. May also supervise and administer specific aspects of the quality system. The incumbent will be systematic, highly organized and articulate, and work in a team environment. Job tasks require interfacing with external suppliers and internal manufacturing, engineering, regulatory, quality, and materials personnel, and senior management. A positive attitude is important while working in a fast-paced manufacturing environment and dealing with shifting priorities.

Essential Duties and Responsibilities:

• Design and maintain the supplier quality management system according to written policies and procedures
• Provide quality guidance to other departments.
• Perform supplier qualification audits, monitor supplier performance, provide supplier program metrics and periodic reports, and manage the supplier corrective action system.
• Ability to frequently travel in the U.S. and internationally.
• Serves as the Chairperson on the Supplier Review Committee (SRC) and ensures ongoing supplier program transparency and open communication between cross-functional departments.
• Establishes and maintains the Supplier Audit Schedule and ensures compliance with this schedule.
• Serves as the supplier quality representative during internal audits and for designated suppliers, as necessary.
• Ensures Quality Agreements are established, where needed, and that any joint periodic business reviews are conducted. Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreement.
• Works 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.
• Takes the initiative to develop systems and processes that: improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
• Reads, writes, and understands specifications and inspection criteria.
• Reads schematics and mechanical drawings.
• 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, Agile and MiniTab).
• Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
• Possess knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards (e.g. ISO 13485).
• Certified or trained to perform quality audits 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. Ability to speak Mandarin is highly desired.

Education Requirements:

• Bachelor's degree from four-year college or university is preferred
• Minimum 5 years related experience and/or training
• Or equivalent combination of education and 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.