Join to apply for the Supplier Quality Engineer II role at Riverpoint Medical .

Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements. Riverpoint Medical, located in Northeast Portland, is hiring a Supplier Quality Engineer II . Our company specializes in designing and manufacturing premium medical devices for Medical, Dental, and Veterinary markets. Our innovative products include suture technologies, sports medicine fibers and anchors, surgical lighting, and specialized needle technologies. Responsibilities include: Supporting supplier quality activities, including developing test methods, equipment acquisition, component validations, and statistical data analysis. Ensuring compliance with industry standards, regulatory, and customer requirements in receiving and supplier processes. Identifying and evaluating non-conformances. Collaborating with suppliers on corrective actions (SCAR). Utilizing statistical tools such as process capability and measurement system analysis, with proficiency in Minitab. Validating and verifying supplier processes to meet internal and external standards. Leading CAPA and non-conformance investigations, working cross-functionally to implement solutions. Applying problem-solving methodologies like DMAIC. Navigation of FDA QSR 21 CFR part 820, EU MDR, and ISO 13485 regulations. Managing quality systems including CAPA, SCAR, and non-conformance trending. Conducting supplier audits, reviews, and feedback processes. Leading supplier development and continuous improvement initiatives. Managing supplier change processes and component qualifications. Coordinating document change processes. Qualifications: Bachelor's Degree in Engineering or related field. Experience with CAPA planning and FMEA. Experience working in ISO 13485 or FDA-regulated environments. Proficiency in Word and Excel; strong technical writing skills. At least 3 years in supplier quality management within FDA-regulated settings, with knowledge of cGMP, QSR, ISO 13485, MDSAP, and MDR. We offer comprehensive benefits including medical, dental, vision, life insurance, 401(k) with company match, paid time off, holidays, and bonus programs. Riverpoint Medical is an equal opportunity employer committed to diversity and inclusion. Details: Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industry: Medical Equipment Manufacturing

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