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Staff Quality Engineer

LocationSan Carlos
TypeOnsite
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

Compensation Range: $164K - $221K

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