Quality Engineer, Medical Devices & Validation

Aptyx; Fenimore (NY); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading medical device company located in New York is seeking a Quality Engineer to support and maintain their Quality Management System (QMS). This role involves regulatory compliance, validation activities, and internal audits while partnering with various teams to improve quality and operational processes. The ideal candidate will have 5–7 years of experience in regulated manufacturing, with strong knowledge of cGMP and ISO standards. A Bachelor's degree in a relevant field is preferred.

Qualifications

• 5–7 years of experience in medical device manufacturing or regulated environments.
• Strong knowledge of cGMP and ISO 13485 requirements.
• Working knowledge of ISO 14971 principles.

Responsibilities

• Support maintenance and improvement of the Quality Management System (QMS).
• Conduct and document internal audits across functions.
• Assist with customer complaint investigations.
• Support compliance with FDA QSR and Good Manufacturing Practices (cGMP).
• Develop and review validation protocols and reports.

Skills

Microsoft Office proficiency

Statistical tools

Technical writing

Data analysis techniques

Collaboration skills

Education

Associate or Bachelor's degree in Engineering, Science, or related field

Tools

ERP systems

Job description

A leading medical device company located in New York is seeking a Quality Engineer to support and maintain their Quality Management System (QMS). This role involves regulatory compliance, validation activities, and internal audits while partnering with various teams to improve quality and operational processes. The ideal candidate will have 5–7 years of experience in regulated manufacturing, with strong knowledge of cGMP and ISO standards. A Bachelor's degree in a relevant field is preferred.