Staff Quality Engineer

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.

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

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