Quality Engineer

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

ob Description: EDDA Technology does work that matters with an outstanding team who believes in making a difference for our medical facilities, clinicians and their patients.

Job Description

A Quality Engineer position is available onsite at EDDA Technology, Princeton, NJ.

Responsibilities

• Work with the quality management team to maintain and update the quality management processes and activities to meet Quality/Regulatory requirements;
• Work closely with product team on maintaining and improving product and process quality (FDA & EUMDR class II medical device);
• Participate in ISO & EUMDR audits and FDA inspections;
• Responsible for QA related internal training;
• Support design inputs/outputs, design reviews, verification & validation (V&V), and design transfer to manufacturing.
• Ensure design controls comply with applicable regulations throughout the lifecycle.
• Support risk management activities per ISO 14971 (hazard analysis, risk assessments).
• Support manufacturing process controls, change control, and production quality.
• Investigate nonconformances and support root cause analysis and CAPA activities under the guidance of the Quality Manager.

Required qualifications

• BS/BA or advanced degree in related discipline.
• 3 – 5 years of experience in the areas of Quality Management, preferably with a manufacturer of medical devices including software.
• Must have strong knowledge of compliance with FDA QMSR and ISO 13485 and EUMDR.
• Successful experience in external audits and inspections.
• Excellent written and verbal communication skills.

Company Introduction: Excellent opportunity with a dynamic, growing medical technology solution company.

EDDA Technology is an innovative leader in the rapidly growing field of surgical AI and intelligent robotic solutions for precision surgery. Pioneering a “fully quantitative, interactive” approach to intelligent imaging analytics and robotic integration, the company has built a proprietary technology platform to facilitate pre-surgical planning and simulation, intra-operative navigation, post-operative evaluation. With its end-to-end enabling platform, EDDA’s goal is to form a comprehensive ecosystem of clinical practice, connection and education to support physicians and patient management in all tiers of hospitals. IQQA® is a registered trademark of EDDA Technology. (www.eddatech.com)

Compensation / Benefits

Salary Range: $90,000 – $115,000; compensation is based on experience, education, and relevant skills. EDDA offers a competitive salary.

• performance-based incentive stock options
• medical and dental insurance
• vision care
• 401k plan
• section 125 health and dependent care (flexible spending) accounts
• paid vacations
• the company sponsors the H1B application