Quality Engineer

Nissha Medical Technologies•Buffalo, NY

About The Position

Nissha Medical Technologies is seeking a Quality Engineer to join its Quality team in Buffalo, New York. The role assures that manufacturing processes comply with product specifications, customer requirements, and regulatory and government requirements. The Quality Engineer controls total quality and establishes methods for evaluating product quality, while developing, modifying, applying, and maintaining quality standards for operating methods, processes, systems, and procedures. The position supports compliance with corporate and regulatory requirements, including ISO 9000 and ISO 13485, QSR, and product specification and drawing tolerances. The Quality Engineer supports product development and validation activities, leads cross-functional improvement efforts, and serves as the primary interface for customer quality requirements for assigned devices. The role investigates manufacturing, customer, and supplier problems; addresses customer quality issues through CAPA; applies Lean Six Sigma methods and quality engineering tools; and implements process improvements. The position also helps troubleshoot manufacturing and engineering activities, reviews and approves product designs, and participates in internal and external audits to support effective implementation of the Quality Management System. Nissha Medical Technologies is a global contract development and manufacturing organization and the medical devices business unit of Nissha Co., Ltd. Its teams design and manufacture medical devices and solutions across patient monitoring, surgical and interventional solutions, precision components, and emerging technologies. The company describes a culture centered on quality, accountability, continuous improvement, teamwork, curiosity, and employee growth.

Requirements

Bachelor of Science degree in Mechanical Engineering or another science-related field.
Minimum 5 years of experience in a quality engineering capacity in a manufacturing environment; medical or pharmaceutical experience is preferred.
Working experience applying statistical methods in quality assurance systems and processes.
Well-developed verbal, numerical reasoning, and analysis skills, with the ability to draw sound conclusions.
Ability to interact with operations management at all levels.
Ability to take initiative, complete tasks accurately and on time, and pay attention to detail.

Nice To Haves

Certified Quality Engineer (CQE) preferred.
Six Sigma Green Belt certification preferred.
Knowledge of 21 CFR 820 and cGMPs.
Ability to develop sound and simple systems to assure ISO and regulatory compliance.

Responsibilities

Assure that manufacturing processes comply with product specifications, customer requirements, and regulatory and government agency requirements.
Control total quality and establish ways of evaluating product quality.
Develop, modify, apply, and maintain quality standards for operating methods, processes, systems, and procedures, ensuring compliance with corporate and regulatory requirements, including ISO 9000 and ISO 13485.
Ensure processes comply with tolerances stated in product specifications and drawings, as well as QSR and ISO standards.
Support product development activities, including DFMEA, PFMEA, PCP, PVP, TMV, and validation protocol reports (IQ, OQ, PQ).
Lead cross-functional teams to improve process and product understanding.
Serve as the primary interface for customer quality requirements for assigned devices and ensure those requirements are met.
Assist in determining and implementing 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.
Review and approve product designs.
Participate in internal and external audits to ensure effective implementation of the Quality Management System (QMS).