Senior Quality Engineer-Operations-CA; opens tab San Diego, CA

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Full Time San Diego, CA, US

Salary Range: $ To $ Annually

About Synchron

Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time.

In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems.

Senior Quality Engineer (Operations)
Quality
Location: San Diego, CA (On-site)

Employment Type: Full-Time

As Senior Quality Engineer (Operations), you will serve as the Quality lead supporting Synchron’s manufacturing operations, contract manufacturers, and supplier network to ensure products are manufactured safely, consistently, and in compliance with applicable regulatory requirements. You will partner closely with Manufacturing Engineering, Supply Chain, Operations, and R&D to establish robust manufacturing processes, support design transfer activities, and drive continuous improvement across production operations.

You will also assist in the development and implementation of Synchron’s QMS. This is a hands-on role requiring regular engagement on the manufacturing floor, with suppliers, and across cross-functional teams.

• Serve as the Quality representative supporting manufacturing operations and production readiness.
• Develop and maintain manufacturing quality plans, inspection methods, acceptance criteria, and process controls.
• Monitor production quality metrics including yield, defects, scrap, and process capability; identify trends and drive continuous improvement.
• Support manufacturing investigations related to nonconforming product, deviations, and production issues.
• Lead root cause investigations using structured problem-solving methodologies and ensure timely implementation of effective CAPAs.
• Support Manufacturing Engineering during implementation of new equipment, tooling, automation, and process improvements.
• Up to 20% travel expected, primarily for contract manufacturer visits and supplier audits.

• Lead or support process validation activities (IQ/OQ/PQ) for manufacturing processes, equipment, software, and inspection systems.
• Develop validation protocols, reports, sampling plans, and acceptance criteria.
• Support manufacturing process characterization and statistical analysis.
• Maintain validated state through periodic review and change assessment.
• Participate in pilot builds and production readiness activities supporting commercialization.
• Manage quality oversight of suppliers and contract manufacturers.
• Conduct supplier qualification, audits, performance monitoring, and quality system assessments.
• Review supplier validation documentation, inspection methods, and process controls.
• Maintain supplier quality agreements and supplier performance scorecards.
• Partner with Supply Chain to resolve supplier quality issues and implement corrective actions.

• Partner with R&D and Manufacturing Engineering to ensure successful transfer of new products into production.
• Develop Process FMEAs, Control Plans, inspection strategies, and manufacturing quality documentation.
• Evaluate manufacturing impact of engineering changes through Change Control processes.
• Support Design Reviews with a focus on manufacturability, inspection, process capability, and production scalability.

• Author and maintain manufacturing quality documentation…