Senior Supplier Quality Engineer - Electronics (PCB, PCBA)
DexcomAbout the role
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.
Meet the team:
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.
Supplier development to improve capabilities of key suppliers and/or materials.
In this particular role, we are seeking a Senior Supplier Quality Engineer with deep expertise in electronics (PCBs) manufacturing and assembly.
Where you come in:
Maintain the supplier quality management system according to written policies and procedures. Will provide key input on compliance and continuous improvement of business processes.
Provide quality guidance to other departments.
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.
Maintains the Supplier Audit Schedule and ensures compliance with this schedule.
May attend and support internal audits by regulatory and other outside agencies.
Establishes and maintains 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 Agreements.
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 a working knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics.
Provides training and guidance to lower level quality engineers and new hires.
Takes the initiative to improve systems and processes that: increase product safety; increase product consistency and conformance to requirements; improve production efficiency and communication; reduce operating and scrap costs.
Reads, writes, 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, 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.
Experience with supplier quality systems development is highly desired.
Possesses knowledge of techniques like six sigma, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics.
Assesses quality performance issues of assigned suppliers using multiple input data streams from Dexcom and the supplier’s process to drive / support supplier development activiti
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