Senior Quality Engineer - Medical Devices & CAPA

Nissha Medical Technologies; Buffalo (NY); In loco; USD 70.000 - 85.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, and vision coverage

401(k) with company match

Paid time off

Descrizione del lavoro

Nissha Medical Technologies in Buffalo, NY is seeking a Quality Engineer to join our Quality team. You will ensure manufacturing processes meet product specifications, customer requirements, and regulatory standards, while leading CAPA investigations and cross‑functional improvements.

You will develop and maintain quality systems, support DFMEA/PFMEA and validation activities, and drive Lean Six Sigma initiatives to improve process capability and product quality for medical devices.

Competenze

• B.S. Degree in Mechanical Engineering or other Science related field.
• Minimum 5 years’ experience in QE capacity engineering in a manufacturing environment; preferably in a medical or pharmaceutical environment
• CQE preferred
• Working knowledge of statistical methods in quality assurance systems and processes

Mansioni

• Ensure processes comply with tolerances stated in product specifications and drawings, and with QSR/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 primary interface for customer quality requirements for specific devices and ensure those requirements are met.
• Assist in determining and implementing test and inspection activities for quality inspection.
• Investigate and analyze manufacturing, customer, and supplier problems.
• Resolve customer quality issues by executing CAPA processes.
• Apply Lean Six Sigma methodologies and quality engineering tools to drive improvements.
• Implement process improvements, including fixtures, tooling, production checks, and testing/inspection devices.
• Establish mechanisms to evaluate, measure, and monitor product quality to improve production efficiency.
• Assist with troubleshooting manufacturing and engineering activities.
• Review and approve product designs.
• Participate in audits to ensure effective QMS implementation.

Conoscenze

QE experience in manufacturing

CQE preferred

Six Sigma Green Belt

Statistical methods in QA

Formazione

B.S. Degree in Mechanical Engineering or related field

Descrizione del lavoro

Nissha Medical Technologies in Buffalo, NY is seeking a Quality Engineer to join our Quality team. You will ensure manufacturing processes meet product specifications, customer requirements, and regulatory standards, while leading CAPA investigations and cross‑functional improvements.

You will develop and maintain quality systems, support DFMEA/PFMEA and validation activities, and drive Lean Six Sigma initiatives to improve process capability and product quality for medical devices.