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Senior Supplier Quality Engineer

SAN DIEGO, CA

Order: 228227
DirectHire

Position Title: Senior QA Engineer – Supplier Quality Engineer

Duration: Permanent

Location: San Diego, CA 92121

Compensation targets:

$95,400 midpoint

10% Target Bonus

$30,000 value of RSU’s payable over 3 years

 

Senior SQE in Engineering:

These roles will support the Electronics commodity.  This position in the Engineering aspect of Supplier Quality will focus on the following:

  • Material qualification

  • Nonconforming material management

  • Change management support (Supplier-initiated changes)   

  • Change order support

  • Supplier development (by commodity and key supplier)

 

Responsibilities:

  • 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 activities.

  • Performs process evaluation of key processes of assigned suppliers to drive / support supplier development activities.

  • Works cross-functionally to track and trend supplier improvements.

  • Conducts failure investigations as needed

  • Travels as needed within in the U.S. and internationally.

  • Assumes and performs other duties as assigned.

 

Required Qualifications:

  • Bachelor's degree in a technical field/discipline

  • 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.

  • 3 years related experience and/or training, or equivalent combination of education and experience.