MedTech Quality Engineer — CAPA & Lean Six Sigma

Regulatory Jobs; Buffalo (NY); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid time off

Life and disability insurance

Professional development opportunities

Job summary

Nissha Medical Technologies is seeking a Quality Engineer to join our Buffalo, NY Quality team. This role ensures manufacturing processes comply with product specifications, customer requirements, and regulatory standards, including ISO 9000 and 13485, while driving continuous improvement.

You will lead DFMEA/PFMEA activities, support product development, and collaborate with cross-functional teams to resolve issues, implement CAPA, and uphold QMS audits.

Qualifications

• 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 experience with the application of statistical methods in quality assurance systems and processes

Responsibilities

• Ensure processes comply with the tolerances stated in product specifications and drawings, as well as QSR and ISO standards.
• Lead cross-functional teams to improve process and product understanding.
• Assist in determining and implementing the test and inspection activities required for quality inspection.
• Investigate and analyze manufacturing, customer, and supplier problems.
• Apply Lean Six Sigma methodologies to drive continuous improvement.

Skills

Quality engineering

Statistical methods

Manufacturing quality

Education

B.S. Degree in Mechanical Engineering

Job description

Nissha Medical Technologies is seeking a Quality Engineer to join our Buffalo, NY Quality team. This role ensures manufacturing processes comply with product specifications, customer requirements, and regulatory standards, including ISO 9000 and 13485, while driving continuous improvement.

You will lead DFMEA/PFMEA activities, support product development, and collaborate with cross-functional teams to resolve issues, implement CAPA, and uphold QMS audits.