Supplier Quality Engineer

Supplier Quality Assurance Engineer:SEC Recruiting is partnering with a leading Medical Device Manufacturing firm in the western Twin Cities metro to hire a full time Supplier Quality Assurance Engineer. The Supplier Quality Assurance Engineer is tasked with ensuring the continued development and enhancement of the quality system, adhering to various industry standards such as ISO 9001, ISO 13485, FDA regulations (CFR Part 820/211), EU MDR, and other relevant guidelines. The role involves supporting investigations related to product complaints and corrective actions, improving supplier quality, and enhancing operational and process controls. The engineer will apply statistical methods and quality principles to drive improvements in product and service quality, with a special emphasis on supplier quality management.Key Responsibilities:Collaborate with cross-functional teams during new product development to ensure product quality and adherence to Quality System requirements.Develop and implement statistical methodologies such as sampling plans, experimental designs, capability studies, SPC, and trend analyses.Lead or participate in corrective actions and problem-solving efforts for process and product-related issues.Establish and update documented procedures and work instructions as necessary.Analyze collected data to perform statistical evaluations and recommend quality improvements.Monitor and report on performance metrics.Educate staff on quality principles, corrective actions, and statistical techniques.Work closely with various departments to resolve quality-related challenges.Maintain product quality through evaluation and disposition of nonconforming materials.Conduct quality system audits and offer guidance on corrective measures.Perform additional duties as needed.Qualifications:Bachelor’s Degree in Engineering or a related technical discipline.1-5 years of experience in Manufacturing/Quality Engineering and/or Quality Systems management.1-5 years of experience working in environments certified under ISO standards.Preferred Experience:1-5 years of experience within regulated industries, such as medical devices, is advantageous.Familiarity with regulatory standards such as QSR and GMP is preferred.Experience with statistical analysis tools and software is highly desirable.