Quality Engineer - Medical Devices, Lean Six Sigma & CAPA

Nissha Medical Technologies; Buffalo (AL); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off

Job summary

Nissha Medical Technologies in Buffalo, NY is seeking a Quality Engineer to assure manufacturing processes meet product specs, regulatory and customer requirements. You will lead cross-functional teams, support DFMEA/PFMEA, and drive process improvements within a robust QMS.

The role requires 5+ years in quality engineering, preferably in medical manufacturing, with CQE preferred. Competitive compensation and benefits offered, with on-site work in Buffalo.

Qualifications

• B.S. degree in Mechanical Engineering or related science field.
• Minimum 5 years of QE engineering in a manufacturing environment; medical/pharma preferred.
• CQE certification preferred.
• Experience applying statistical methods in quality assurance systems.

Responsibilities

• Ensure processes comply with product specifications, QSR/ISO standards, and regulatory requirements.
• Lead cross-functional teams to improve process and product understanding.
• Serve as primary interface for customer quality requirements for devices.
• Assist in determining test and inspection activities for quality.
• Investigate and resolve manufacturing and supplier problems; CAPA when needed.
• Apply Lean Six Sigma tools to drive continuous improvement.
• Participate in internal and external audits to support the QMS.

Skills

Quality engineering

Statistical methods

Cross-functional teamwork

Process improvement

Six Sigma

Education

B.S. Mechanical Engineering

Healthcare QE experience

CQE preferred

Job description

Nissha Medical Technologies in Buffalo, NY is seeking a Quality Engineer to assure manufacturing processes meet product specs, regulatory and customer requirements. You will lead cross-functional teams, support DFMEA/PFMEA, and drive process improvements within a robust QMS.

The role requires 5+ years in quality engineering, preferably in medical manufacturing, with CQE preferred. Competitive compensation and benefits offered, with on-site work in Buffalo.