Sr QA Engineer

DexCom-posted 3 months ago
$87,000 - $145,000/Yr
Full-time • Mid Level
Mesa, AZ
5,001-10,000 employees
Miscellaneous Manufacturing
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The Senior level Supplier Quality Engineer engages suppliers in three fundamental means: Supplier evaluation to drive supplier assessments to determine supplier abilities to meet Dexcom requirements, Material qualification to drive material assessments to determine conformance to requirements, and Supplier development to improve capabilities of key suppliers and/or materials.

  • Perform supplier qualification audits, monitor supplier performance, provide information for supplier program metrics and periodic reports, and assist in management of the supplier corrective action system.
  • Establish and maintain supplier Quality Agreements, where needed, and any joint periodic supplier business reviews.
  • Review and approve supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreements.
  • Work as a member of the design team, assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
  • Conduct failure investigations as needed.
  • Maintain the supplier quality management system according to written policies and procedures.
  • Assess quality performance issues of assigned suppliers using multiple input data streams from Dexcom and the supplier's process to drive/support supplier development activities.
  • Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
  • Possess manufacturing experience in injection molding, electronics (PCB and PCBA manufacturing), wire manufacturing, machining, and assembly.
  • 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.
  • Possess knowledge of techniques like six sigma, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics.
  • Ability to manage shifting priorities with minimal difficulties.
  • Experience in providing training and guidance to lower level quality engineers and new hires.
  • A full and comprehensive benefits program.
  • Growth opportunities on a global scale.
  • Access to career development through in-house learning programs and/or qualified tuition reimbursement.
  • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
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