Job: QA engineer

A startup company in the field of medical devices looking for a skilled and energetic QA engineer with “hands-on” and “can-do” approach who wants to join our fast-growing company.

The QA engineer is the team’s technical and functional authority in testing and verifying our new visionary technology. quality testing of company’s products and technologies. S\he will work with the R&D team and report to the CTO. 

Responsibilities 

• Design, write, and maintain testing documentation and protocols for complex embedded system in accordance with medical device standards and selected regulations. 

• Analyze functional and technical documents (product requirement, certification, etc.)

• Execute functional software and hardware testing in-house and at customer sites including, product test plan, test case scenarios and reports. 

• Plan and build testing environment and tools that comply with requirements, intended use and regulatory guidelines. 

• Support lab testing and certification process of hardware 

• Be up to date with medical regulation and guidelines related to company product testing.   

• Ensure that the progress is according to the quality requirements.

• Oversee and maintain testing log files, severity and triage of bugs and defects. 

• Where applicable, support field testing, customer support and MRB activities. 

Required experience  

• 2+ years of QA experience testing WEB & Mobile Applications.

• Experience with end-to-end testing of embedded medical device systems coupled with digital health.

• Experience in testing both Client & Server sides.

• Experience with writing STP, STD and protocols. 

• Experience with system certification process- a plus 

• Experience with in-vitro and clinical testing- a plus 

• Experience with medical device standards- a plus

• Experience in fast-paced, start-up like environment- a plus

Qualifications 

• Well organized and methodologic attitude. 

• Creative and thoughtful “hands-on” leader with “can-do” approach.

• Self-motivated, ability to work autonomously in a small team environment

• Out of the box and a “big-picture” thinker.

• Ability to focus on deadlines and deliverables.

• Ability to drill down and find the root cause of problems.

• Excellent verbal and written communication skills (Fluent English)

• Must be comfortable working in an environment controlled by standards and regulations, such as Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and Quality System Regulations (QSRs), both US and international.

• Ability/ willingness to travel internationally, up to 20%.