Regulatory & Quality Engineer

QRA Strategies LLC helps early stage Med Tech companies build their first Quality Management System and clear initial operational hurdles without slowing engineering. We treat compliance as an operational milestone. Startups often face limited engineering bandwidth and an operational backlog that becomes technical debt. Mismanaged early, it burns capital and delays product launches. We close that gap with precise quality strategy and execution.

Our team embeds with clients to build the operations required to manufacture devices while asking minimal time from core engineers. Our framework yields tangible results, demonstrated by recently securing a major foundational certification across four global markets for an early stage client.

This is an on site Quality Engineer position based in the San Francisco Bay Area. Your objective is to drive immediate execution on quality system documentation, equipment readiness, and manufacturing operations. You will actively build and manage incoming inspection activities, equipment qualifications (IQ), risk management files, CAPAs, and nonconformance investigations.

You will eliminate operational bottlenecks by independently drafting controlled documents, executing line validation action items, and organizing audit preparation materials. You will work directly with operations and quality strategists to ensure accurate record keeping and structured data management. This role requires hands on execution to commercialize medical devices and optimize the underlying economics of efficient manufacturing pathways.

• Proven experience with Med Tech quality systems and medical device manufacturing environments (ISO 13485 / FDA QSMR).
• Exceptional written communication skills for drafting technical procedures, inspection protocols, and engineering rationales.
• Highly organized with the proven ability to manage multiple complex production workflows autonomously in a fast paced startup environment.
• Bachelor's degree or higher in engineering, manufacturing operations, life sciences, or a related discipline.
• Located in the San Francisco Bay Area with the ability to maintain a regular on site presence.
• Direct experience managing document control systems, building risk management files, and executing hardware validation projects.
• Availability for a full time workload of approximately 40 hours per week.
• Ability and willingness to operate as an independent 1099 contractor.