Quality Engineer

Nissha•Buffalo, NY

13d•$70,000 - $85,000

About The Position

Nissha Medical Technologies is seeking a Quality Engineer to join its Quality team in Buffalo, New York. The position ensures that manufacturing processes comply with product specifications, customer requirements, and regulatory and government agency requirements. The Quality Engineer controls total quality and establishes methods for evaluating product quality. The role develops, modifies, applies, and maintains standards for quality operating methods, processes, systems, and procedures, ensuring compliance with corporate and regulatory requirements, including ISO 9000 and ISO 13485 standards. It also supports product development, customer and supplier quality issue resolution, process improvement, manufacturing troubleshooting, product design reviews, and internal and external audits. The expected salary range is $70,000–$85,000. Actual compensation depends on experience, skills, qualifications, and geographic location. Nissha Medical Technologies offers medical, dental, and vision coverage, a 401(k) with company match, paid time off, life and disability insurance, and professional development opportunities.

Requirements

Bachelor of Science degree in Mechanical Engineering or another science-related field.
At least 5 years of experience in a quality engineering capacity in a manufacturing environment; preferably in a medical or pharmaceutical environment.
Working experience applying statistical methods in quality assurance systems and processes.
Provide recommendations based on business system results.
Well-developed verbal, numerical reasoning, and analytical 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 demonstrate 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, simple systems to ensure ISO and regulatory compliance.

Responsibilities

Ensure processes comply with tolerances 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 specific devices and ensure those requirements are met.
Assist in determining and implementing required test and inspection activities.
Investigate and analyze manufacturing, customer, and supplier problems.
Resolve customer quality issues through 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 and 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).