Senior QA Engineer

Dexcom • San Diego, CA

1d • Remote

About The Position

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.

Requirements

• Possess manufacturing experience in the following processes: Injection molding, Electronics (PCB and PCBA manufacturing), Wire manufacturing, Machining, Assembly.
• Possess knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards (e.g. ISO 13485).
• Reads schematics and mechanical drawings and provides input into revisions, as needed.
• Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
• Possess knowledge of techniques like six sigma, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics.
• Take 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.
• Applies proficient computer skills in the use of Microsoft Office and database applications.
• Ability to manage shifting priorities with minimal difficulties.

Nice To Haves

• Certified or trained to perform quality audits is highly desired.
• Assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.

Responsibilities

• 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.
• Establish and maintain 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.
• Reads, writes, and understands specifications and inspection criteria.
• Reads schematics and mechanical drawings and provides input into revisions, as needed.
• Conducts failure investigations as needed
• Maintains the supplier quality management system according to written policies and procedures.
• Provide key input on compliance and continuous improvement of business processes.
• Works cross-functionally to track and trend supplier improvements.
• Work and communicate effectively and professionally in a team environment with minimal supervision.
• Assumes and performs other duties as assigned.
• Provides training and guidance to lower level quality engineers and new hires.
• 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.
• Performs process evaluation of key processes of assigned suppliers to drive / support supplier development activities.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior