Clinical Software QA Engineer

Location

Berkeley, CA | United States

Job description

The Opportunity

This is an opportunity to serve as a Software Quality Assurance Engineer at a well-funded, mission-first medical device company developing an AI-powered intravascular ultrasound platform to significantly improve patient imaging and dramatically affect care for health conditions that affect 200 million people globally. We are looking for someone to join our San Jose based team to help lead our software quality assurance in a field that combines stringent regulatory standards with advanced technology.

This is an opportunity with a lot of growth and impact potential.

Potential Responsibilities

Your responsibilities can range from:

• Demonstrating a strong Quality Engineering (QE) background in systems, particularly Class II, with some experience in Class III systems.
• Developing and implementing a Quality Management System (QMS) from the ground up, or significantly updating an existing QMS.
• Conducting and preparing for external audits, and engaging in audit readiness activities.
• Fitting philosophically with a startup environment, by maintaining a minimal, efficient, and effective QMS and confidently guiding our approach.
• Excelling in risk management, supporting design teams in all risk management activities, and defining output documents.
• Creating Risk Management templates, actively participating in the Risk Management Team, and authoring Risk Management Reports (RMR).
• Handling Manufacturing (MFG) transfer for multiple types of products.
• Managing supplier quality significantly, with experience in outsourcing manufacturing and design being advantageous.
• Being adaptable and willing to take on various roles within the project, demonstrating a hands-on approach.
• Applying exceptional analytical and problem-solving skills.
• Demonstrating strong communication and collaboration skills.
• Staying highly motivated and capable of handling multiple projects, meeting deadlines in a timely manner.
• Being results-oriented while balancing other business considerations.
• Upholding high integrity, demonstrating a tremendous work ethic, and possessing a passion for success.

Preferred Qualifications:

• Strong knowledge of relevant standards: ISO 13485, ISO 14971, operational knowledge of IEC 62304 (software development life cycle) 
• Proficient with relevant software programs, i.e. Linux (Ubuntu), Scripting tools (Python), Jira, Confluence, Jama, QMS platforms, i.e. Greenlight Guru

We encourage applications from candidates of all backgrounds and experiences, even if you don't meet every qualification listed. If you believe you can excel in this role and contribute to our team, we encourage you to apply. Your unique perspective may be exactly what we need.

Base Salary Range:

$120,000 - $145,000

Job tags

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