Senior QA Engineer - Supplier Quality

Dexcom

Phoenix, Arizona, United States

Phoenix, Arizona, United States

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About

Meet the team The Senior level Supplier Quality Engineer engages suppliers in three fundamental ways: Supplier evaluation to drive supplier assessments to determine the supplier’s abilities to meet Dexcom requirements. Material qualification to drive qualification of components and conformance to requirements. Supplier development to improve capabilities of key suppliers and/or materials. Where you come in You have approval and qualification of new components and assemblies at suppliers. Qualification includes process validations consisting of IQ, OQ, and PQ. You can assess quality performance issues of suppliers using multiple input data streams from Dexcom and the supplier’s process to drive / support supplier development activities. You are responsible for non‑conformance investigations of supplier issues, evaluating and approving corrective actions, and performing verification of effectiveness. You take the initiative to develop systems and processes that improve product safety, increase product consistency and conformance to requirements, maintain the supplier quality system, improve production efficiency, and reduce operating and scrap costs. You work cross‑functionally to track and trend supplier improvements and ongoing projects. You possess an in‑depth and professional level of knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards including ISO 13485 & ISO 14971. You effectively utilize knowledge of techniques such as six sigma methodologies, gauge R&R studies, process capability (Cpk/Ppk), lean manufacturing, sampling plans, and statistics. What makes you successful You have a strong background in any of the following processes: injection molding, extrusion, stamping, electronics (PCB and PCBA manufacturing), wire manufacturing, machining and assembly. You have excellent communications and collaboration skills with internal and external teams including quality engineering, manufacturing, receiving inspection and supplier representatives. You have the ability to manage work and shifting priorities in a fast‑paced manufacturing environment. You have previous medical device experience in quality engineering or supplier quality. You are able to travel, as needed, domestically and internationally. You have previous training and/or certification for quality audits. What you’ll get A front‑row seat to life‑changing CGM technology. 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 employees, customers, and the communities we serve. Travel required 25% to 50% domestic and international travel. Experience and education requirements Typically requires a bachelor’s degree in a technical discipline and a minimum of 5‑8 years related experience. Alternatively, a master’s degree and 2‑5 years equivalent industry experience, or a PhD and 0‑2 years’ experience. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Salary $87,000.00 - $145,000.00
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Phoenix, Arizona, United States

Languages

English

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