Quality Engineer - Med Devices, CAPA & Lean Six Sigma

Nissha Medical Technologies; New York (NY); On-site; USD 70,000 - 85,000; Full time

Job summary

Nissha Medical Technologies is seeking a Quality Engineer in Buffalo, NY to assure manufacturing processes meet product specs, customer requirements, and regulatory standards. You will develop, modify, and maintain quality methods, while leading CAPA and cross-functional improvements.

The role emphasizes DFMEA/PFMEA, IQ/OQ/PQ protocols, and interface with customers to ensure compliance with ISO 9000/13485 and cGMPs. A BS in engineering and 5+ years QE experience are required.

Qualifications

• B.S. degree in Mechanical Engineering or related field.
• Minimum 5 years' QE engineering experience in manufacturing.
• CQE certification preferred.
• Proficient use of statistical methods in QA systems and processes.

Responsibilities

• Ensure processes meet product specifications, tolerances, QSR, and ISO standards.
• Lead DFMEA, PFMEA, PCP, PVP, TMV, and validation protocols (IQ/OQ/PQ).
• Lead cross-functional teams to improve processes and product understanding.
• Interface with customers to ensure quality requirements are met.
• Implement test and inspection activities for quality control.
• Investigate manufacturing, customer, and supplier issues and drive CAPA.

Skills

Quality engineering

Statistical methods

Cross-functional teamwork

Problem-solving

Education

B.S. in Mechanical Engineering

Tools

CQE preferred

Six Sigma Green Belt

21 CFR 820 / cGMPs

ISO 9000 / 13485 knowledge

Job description

Nissha Medical Technologies is seeking a Quality Engineer in Buffalo, NY to assure manufacturing processes meet product specs, customer requirements, and regulatory standards. You will develop, modify, and maintain quality methods, while leading CAPA and cross-functional improvements.

The role emphasizes DFMEA/PFMEA, IQ/OQ/PQ protocols, and interface with customers to ensure compliance with ISO 9000/13485 and cGMPs. A BS in engineering and 5+ years QE experience are required.