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Supplier Quality Engineer II

About Dexcom:
Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.
Summary:
SQE II: The incumbent is responsible for performing all of the duties of a Supplier Quality Engineer II, as stated in this job description. Performs tasks with moderate oversight from the manager and/or designated senior level supplier QEs. Will assist senior quality engineers in the performance of their duties and will support, evaluate, revise, and implement specific aspects of the quality system, as assigned. The incumbent will be systematic, highly organized and articulate, and work well in a team environment. Job tasks require interfacing with external suppliers, internal manufacturing, engineering, regulatory, quality, materials, and operations personnel, and senior management. Will provide guidance and training to technical and administrative personnel, and incoming new hires, as assigned. A positive attitude is important while working in a fast-paced manufacturing environment and dealing with shifting priorities.
Essential Duties and Responsibilities:
Maintain the supplier quality management system according to written policies and procedures. Will provide input on compliance and continuous improvement of business processes.
Provide quality guidance to other departments.
Review supplier material, product and process validations and documents to ensure qualification and compliance requirements are met.
Provide support in conducting supplier audits, monitor supplier performance, provide information for supplier program metrics and periodic reports, and assist in administration of the supplier corrective action system.
Ability to travel in the U.S. and internationally.
Transitions into an active participant to the Supplier Review Committee (SRC) meetings and ensures ongoing supplier program transparency and open communication between cross-functional departments.
Maintains the Supplier Audit Schedule and monitors compliance with this schedule, on an ongoing basis.
May attend and support internal audits by regulatory and other outside agencies.
Transitions to establishing and maintaining 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 Agreement.
Work in a team environment with R&D and Operation Engineering, as required. Some type of activities may include assisting with designing processes and quality system requirements with the supplier.
Have knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics; utilizing these techniques as appropriate per Dexcom and/or industry recognized standards.
Provides training and guidance to lower level quality engineers and new hires
Takes the initiative to suggest systems and process improvements that: increase product safety; increase product consistency and conformance to requirements; improve production efficiency and communication; reduce operating and scrap costs.
Reads 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 and Agile).
Has understanding of Design Failure Mode Effect Analysis (dFMEA) and Process Failure Mode Effect Analysis (pFMEA).
Possess a basic understanding of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards including ISO 13485.
Previous training and/or certification to perform quality audits is highly desired.
Experience with supplier quality programs is highly desired.
Assumes and performs other duties as assigned.
Required Qualifications:
Enter minimum objective qualifications required such as years of functional experience, demonstrated expertise in specific areas, etc.
Preferred Qualifications:
Enter qualifications preferred, such as certifications, industry experience, etc.
Education Requirements:
Bachelor's Degree in a scientific or related discipline is preferred. A minimum of two years' of relevant QA work experience in the medical device manufacturing or subcontracting industry, preferably with supplier quality experience. An equivalent combination of education and experience will be considered.
Travel Required:
0 €“ 24%
Supervisory Responsibilities:
This job does not have supervisory responsibilities.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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