Staff Quality Engineer

Nautilus Biotechnology•San Carlos, CA

About The Position

At Nautilus, we have a big and important mission: improve the health of millions by unleashing the potential of the proteome to accelerate drug development and enable a new world of precision and personalized medicine. We are developing a single-molecule protein analysis platform of unprecedented sensitivity, scale, and ease of use that we believe will democratize access to the proteome – one of the most dynamic and valuable sources of biological insight. To accomplish this, we are pursuing hard scientific problems with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across a wide range of disciplines. We are hiring a strategic Staff Quality Engineer to join our growing team. The Quality Engineer will provide strategic quality leadership during the transition of a complex instrument and consumable from late-stage prototype through design lock and into manufacturing scale. This role architecturally defines supplier and manufacturing quality strategy, anticipates systemic risk, and drives cross-functional alignment to ensure long-term product robustness and scalability. As the primary quality authority, this role will define supplier and manufacturing quality frameworks, anticipate systemic risks, and influence cross-functional and leadership decisions to ensure scalable, robust product performance. While primarily strategic in scope, this individual will also step in hands-on when needed to support critical builds, supplier issues, or manufacturing readiness milestones.

Requirements

10+ years of progressive experience in Quality Engineering, Supplier Quality, or Manufacturing Quality
Bachelor’s degree in Engineering, Quality, Manufacturing, or related field
Proven experience:
Demonstrated experience defining quality strategy during design lock and manufacturing scale-up
Experience qualifying and overseeing Contract Manufacturing Organizations
Strong systems-level root cause, risk assessment, and cross-functional influence skills
Experience in regulated or highly controlled environments preferred

Responsibilities

Define and own supplier and manufacturing quality strategy for critical components, subassemblies, and manufacturing phases
Anticipate systemic quality risks and develop proactive mitigation frameworks that influence design, sourcing, and operational decisions upstream
Identify patterns across suppliers, builds, and design iterations, surfacing root causes and enterprise-level implications to leadership
Establish scalable quality approaches that support transition from prototype to sustained production
Translate complex quality data, inspection findings, and risk assessments into clear narratives that guide leadership trade-off decisions
Influence upstream design and sourcing decisions to prevent downstream failure modes. Drive supplier corrective action strategies that address systemic issues, not isolated defects.
Architect supplier quality planning and readiness models for critical suppliers and CMO onboarding
Define acceptance strategies, control frameworks, and oversight models that ensure long-term supplier capability
Lead qualification strategy for Contract Manufacturing Organizations, establishing scalable governance and performance metrics
Act as quality program lead during pilot builds, production transfer, and early manufacturing scale
Ensure manufacturing documentation, control plans, and inspection systems support repeatable quality at scale
Establish success metrics and quality indicators that inform ongoing production health
Lead complex root cause investigations with a systems-level perspective
Mentor cross-functional partners and potentially junior quality engineers in risk assessment, investigation rigor, and quality thinking
Shape quality culture by modeling principled decision-making and balanced risk judgment
Influence long-term evolution of Nautilus’ quality systems and methodologies