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

Responsibilities include:

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 solutions 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, and 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, and excellent benefits including medical and dental insurance, vision care, 401k plan, section 125 health and dependent care (flexible spending) accounts, and paid vacations. The company sponsors the H-1B application.

Send applications to:

hiring@edda-tech.com

Pay:

$90,000.00 - $115,000.00 per year

Benefits:

401(k) Dental insurance Flexible spending account Health insurance Paid time off Vision insurance Application Question(s): How many years of work experience do you have with

FDA QSMR

compliance? How many years of work experience do you have with EU MDR audits? How many years of work experience do you have with CAPA procedures? Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?

Experience:

ISO 13485

3 years (Required) Risk management: 3 years (Required) Design controls: 3 years (Required) Ability to

Commute:

Princeton, NJ 08540 (Required)

Work Location:

In person