Quality Engineer at Nissha

Buffalo, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Jul, 26

Salary

100000.0

Posted On

29 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality engineering, ISO 9000, ISO 13485, DFMEA, PFMEA, Validation protocols, CAPA, Lean Six Sigma, Statistical methods, Quality management systems, 21 CFR 820, cGMP, Process improvement, Root cause analysis, Technical documentation, Cross-functional leadership

Industry

Medical Equipment Manufacturing

Description

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., 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. What You Will Do Nissha Medical Technologies is looking for a Quality Engineer to join our Quality team. This position is responsible for assuring 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. * Ensure processes complies 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. * Implements 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). What You Bring Core Qualifications * 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 Preferred Qualifications * Experience in QE capacity engineering in a manufacturing environment; preferably in a medical or pharmaceutical environment * CQE preferred * Six Sigma Green Belt Certification preferred Professional Traits We Value * 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 Compensation & Benefits The expected salary range for this position is $80,000– $100,000 annually. Actual compensation will be determined based on experience, skills, qualifications, and geographic location. 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. Equal Opportunity Statement Nissha Medical Technologies is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected status under applicable law.

Responsibilities

The Quality Engineer is responsible for ensuring manufacturing processes comply with product specifications, customer requirements, and regulatory standards like ISO 13485. They will lead cross-functional teams to resolve quality issues, manage CAPA processes, and oversee validation activities.