Quality Engineer - Medical Devices (ISO 13485)

Balda-C-Brewer; New York (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Balda-C-Brewer is seeking a Quality Engineer (ISO 9001, 13485) in Ontario, CA. This full-time professional role supports the Quality Management System, product realization, and manufacturing process controls with cross-functional collaboration.

You will develop quality plans, control plans, and procedures, and lead validations including statistical analysis, audits, and CAPA/NCR processes to ensure regulatory compliance and product quality.

Qualifications

• Minimum 5 years in quality engineering or QA leadership.
• Experience with ISO 9001 and ISO 13485 environments.
• Familiar with FDA QSR or medical device regulations.

Responsibilities

• Develop quality plans, control plans, and procedures for new products.
• Lead validations and statistical analyses for process controls.
• Prepare and audit quality systems, CAPA and NCR processes.
• Collaborate with cross-functional teams across Quality, Engineering, and Operations.
• Investigate customer complaints and drive corrective actions.

Skills

Quality engineering

ISO 9001

ISO 13485

Statistical analysis

PC-DMIS

Minitab

Caliper / Micrometer

GD&T reading

Education

ISO 9001 / ISO 13485 training

ASQ CQE / CQA / CQM

Bachelor's in Engineering or Quality

Tools

PC-DMIS

Minitab

Excel

MS Access

Job description

Balda-C-Brewer is seeking a Quality Engineer (ISO 9001, 13485) in Ontario, CA. This full-time professional role supports the Quality Management System, product realization, and manufacturing process controls with cross-functional collaboration.

You will develop quality plans, control plans, and procedures, and lead validations including statistical analysis, audits, and CAPA/NCR processes to ensure regulatory compliance and product quality.