Staff Quality Assurance Engineer

Why Telos Health?

At Telos Health we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke a disease that impacts close to a million people a year in the U.

S., and 10 million worldwide. Not only is Telos changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without.

We are actively building a team who is focused on developing novel solutions for this complex disease a disease in which one in four adults will face in their lifetime.

What you will do :

This position provides Quality Engineering expertise to support the development, manufacture and distribution of Imperative Care (Telos Health) medical device products to ensure our products and services meet the highest quality standards and are consistent with the Company’s Quality Policy and Quality Objectives.

• Implement and maintain Quality Management System processes, procedures, and techniques.
• Provide quality support for medical device R&D and manufacturing activities throughout all phases of the product development process (e.

g. requirement development, specification development, verification and validation testing, design transfer, risk assessment, usability, design change control).

• Participate and contribute to the development of product design history file and ensure compliance to internal processes and external standards and regulations.
• Perform Document Control activities.
• Collaborates with team members to define requirements, specifications, testing, and component / product acceptance activities.
• Participate in risk management process ensuring that all the risks were properly identified / assessed and update risk management files accordingly.
• Direct interaction with suppliers to qualify and maintain approved supplier status, as well as oversee supplier process validation activities.
• May be required to evaluate supplier notification of change and recommend necessary actions to maintain compliance.
• Review DCO’s involving product or process changes to ensure consistency with company procedures and quality system compliance.
• Provides training on the use of the procedures to promote compliance with Quality System and Regulations to a broad audience.

What you bring :

• Bachelor’s degree in related field (science, industrial operations, mechanical, biomedical, or electrical engineering) and a minimum of 8 years’ work experience (or Master’s and 6+ years) in the medical device, or related regulated industry experience.
• Experience working with electro-mechanical medical device, robotics, or medical software is highly desired.
• Experience in Quality, Manufacturing, or Research and Development experience in a medical device or other regulated industry.
• Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820, ISO 13485, 14971; IEC 60601-1, IEC 62304 medical device software, cybersecurity, and related regulations
• Experience with Quality Control (IQC, In process inspection etc.)
• Experience addressing supplier or process issues (CAPAs, NCMR / NCRs, SCARs, etc.)
• Excellent communications skills (both written and verbal)
• Must be able to write clear, concise, and well thought out technical documentation with a focus on element of traceability, external standard or regulations rationale, risk management.
• Must be able to perform multiple tasks concurrently with accuracy.
22 days ago