Quality Engineer

Nissha•Buffalo, NY

About The Position

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., Ltd., 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. We foster an environment where curiosity is encouraged, teamwork is valued, and individuals are empowered to grow their skills and careers. 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.

Requirements

B.S. Degree in Mechanical Engineering or other Science related field
Minimum 5 years’ experience in QE capacity engineering in a manufacturing environment
Working experience with the application of statistical methods in quality assurance systems and processes
Strong written and oral communication skills
Knowledge of 21 CRF 820 and cGMP’s
Ability to develop sound and simple systems to assure ISO and regulatory compliance
Provide recommendations based on business system results
Ability to interact with operations management at all levels

Nice To Haves

Experience in QE capacity engineering in a manufacturing environment; preferably in a medical or pharmaceutical environment
CQE preferred
Six Sigma Green Belt Certification preferred

Responsibilities

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.
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.
Ensure processes comply with the tolerances stated on the product specification and drawings QSR and ISO standards.
Support product development activities i.e. DFMEA, PFMEA, PCP, PVP, TMV, and validation protocol reports IQ, OQ, PQ.
Lead cross functional teams to improve process and product understanding.
Act as main interface for all customer quality requirements for specific devices and responsible for meeting requirements.
Assist in determination and implementation of test and inspection activities required for quality inspection.
Investigate and analyze manufacturing, customer, and supplier problems.
Resolve customer quality issues by executing Corrective Action Preventive Action (CAPA) processes.
Use Lean Six Sigma methodology and quality engineering tools to achieve continuous improvement.
Implement process improvements including fixtures, tooling, production checks, testing/inspection devices.
Establish mechanism to evaluate, measure, monitor and/or quality in our products to improve efficiency of the production process.
Assist in trouble shooting in manufacturing, and engineering activities.
Review and approve product design.
Participate in internal/external audits to ensure the effective implementation of Quality Management System (QMS).