Quality Engineer - Medical Devices | ISO 13485, FDA

Imigrus; Princeton (NJ); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Health insurance

401k plan

Paid vacations

H1B sponsorship

Job summary

EDDA Technology, a leader in surgical AI and intelligent robotic solutions, seeks a Quality Engineer to work onsite at Princeton, NJ. You will support QA activities, design controls, V&V, and risk management for a class II medical device ecosystem.

Responsibilities include maintaining QMS, supporting audits/inspections, and partnering with design and manufacturing to ensure compliant product development and manufacturing processes.

Qualifications

• BS/BA or advanced degree in a related discipline.
• 3–5 years of experience in quality management, preferably with a medical device manufacturer.
• Strong knowledge of FDA QMSR and ISO 13485 and EUMDR.
• Experience in external audits and inspections.
• Excellent written and verbal communication skills.

Responsibilities

• Maintain and update the quality management processes and activities to meet regulatory requirements.
• Collaborate with product team to maintain and improve product and process quality (FDA & EUMDR class II medical device).
• Participate in ISO & EUMDR audits and FDA inspections.

Skills

FDA QMSR compliance

ISO 13485

EUMDR

Audit & inspections

Quality management

Education

BS/BA or advanced degree in related discipline

Job description

EDDA Technology, a leader in surgical AI and intelligent robotic solutions, seeks a Quality Engineer to work onsite at Princeton, NJ. You will support QA activities, design controls, V&V, and risk management for a class II medical device ecosystem.

Responsibilities include maintaining QMS, supporting audits/inspections, and partnering with design and manufacturing to ensure compliant product development and manufacturing processes.