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Staff Quality Assurance Engineer

2 months ago

Campbell, California, United States Telos Health Full time
About Telos Health

We are a pioneering healthcare technology company developing innovative robotic-assisted technologies and interventional capabilities to revolutionize the treatment of ischemic stroke. Our mission is to bring life-changing treatments to the global population, addressing a disease that affects nearly a million people in the US and 10 million worldwide.

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring our medical device products meet the highest quality standards and comply with regulatory requirements.

Key Responsibilities
  • Implement and Maintain Quality Management System Processes

Develop, implement, and maintain Quality Management System processes, procedures, and techniques to ensure compliance with regulatory requirements and company policies.

Provide Quality Support for Medical Device R&D and Manufacturing

Provide quality support for medical device R&D and manufacturing activities throughout all phases of the product development process, including requirement development, specification development, verification and validation testing, design transfer, risk assessment, usability, and design change control.

Participate in Risk Management and Document Control

Participate in risk management processes to ensure all risks are properly identified and assessed, and update risk management files accordingly. Perform Document Control activities to ensure compliance with regulatory requirements.

Collaborate with Team Members and Suppliers

Collaborate with team members to define requirements, specifications, testing, and component/product acceptance activities. Directly interact with suppliers to qualify and maintain approved supplier status, as well as oversee supplier process validation activities.

Review and Evaluate Supplier Notifications and DCOs

Review and evaluate supplier notifications of change and recommend necessary actions to maintain compliance. Review DCOs involving product or process changes to ensure consistency with company procedures and quality system compliance.

Provide Training and Support

Provide training on the use of procedures to promote compliance with Quality System and Regulations to a broad audience.

Requirements
  • Education and Experience

Bachelor's degree in a 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.

Technical Skills and Knowledge

Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820, ISO 13485, 14971; IEC, IEC 62304 medical device software, cybersecurity, and related regulations.

Soft Skills

Excellent communications skills (both written and verbal), with the ability to write clear, concise, and well-thought-out technical documentation with a focus on element of traceability, external standard or regulations rationale, risk management.

Additional Requirements

Ability to perform multiple tasks concurrently with accuracy.