Quality Engineering S

About Nissha Medical Technologies Nissha Medical Technologies (NMT) is a global Contract Development and Manufacturing Organization (CDMO) where people, purpose, and technology come together to advance healthcare. Headquartered in the United States, NMT is the medical devices business unit and a wholly owned subsidiary of Nissha Co., a publicly traded Japanese company based in Kyoto, Japan (TSE: 7915). Across our global organization, our teams collaborate to design and manufacture innovative medical devices and solutions that make a real difference in patients’ lives. We partner closely with our customers to solve complex challenges, move ideas forward, and support products from concept through commercialization. Our work spans patient monitoring, surgical and interventional solutions, precision components, and emerging technologies, all grounded in a strong culture of quality, accountability, and continuous improvement. At Nissha Medical Technologies, we believe our success is driven by our people. If you’re motivated by meaningful work, collaboration, and the opportunity to help shape the future of healthcare, you’ll find a place to belong at NMT. Nissha Medical Technologies is looking for a Quality Engineer to join our Quality team in Buffalo, NY! This Position is Responsible to assure that manufacturing processes comply with the product specification, customer requirements, and regulatory/government agencies requirements. Control total quality and establish ways of evaluating the quality of products. Responsible to develop, modify, apply, and maintain, standards for quality operating methods, processes, systems, and procedures and ensure compliances to corporate and regulatory requirements including ISO 9000 and 13485 standards. Serve as the primary interface for all customer quality requirements for specific devices and ensure those requirements are met. Assist in determining and implementing the test and inspection activities required for quality inspection. Investigate and analyze manufacturing, customer, and supplier problems. Resolve customer quality issues by executing Corrective and Preventive Action (CAPA) processes. Apply Lean Six Sigma methodologies and quality engineering tools to drive continuous improvement. Implement process improvements, including fixtures, tooling, production checks, and testing and inspection devices. Establish mechanisms to evaluate, measure, and monitor product quality to improve production process efficiency. Assist with troubleshooting manufacturing and engineering activities. Participate in internal and external audits to ensure the effective implementation of the Quality Management System (QMS). Degree in Mechanical Engineering or other Science related field Minimum 5 years’ experience in QE capacity engineering in a manufacturing environment; preferably in a medical or pharmaceutical environment Working experience with the application of statistical methods in quality assurance systems and processes Ability to develop sound and simple systems to assure ISO and regulatory compliance Well-developed verbal, numerical reasoning and analysis sills with ability to draw sound conclusions Ability to interact with operations management at all levels In addition, Nissha Medical Technologies offers a competitive total rewards package including medical, dental, and vision coverage, 401(k) with company match, paid time off, life and disability insurance, and professional development opportunities. Nissha Medical Technologies is an Equal Opportunity Employer.