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About the Role

The Staff Quality Systems & Compliance Engineer is a foundational role within MLI’s Quality organization, owning the infrastructure that keeps our quality management system (QMS) running and our compliance posture inspection-ready. This individual will be the operational owner of ZenQMS — MLI’s eQMS — and will lead day-to-day execution across all quality system programs. This is a hands-on, high-ownership role for someone who thrives on building systems from scratch and making them stick in a fast-moving, mission-driven environment.

Responsibilities

Own configuration, administration, and continuous improvement of ZenQMS across all active and future modules.
Train personnel on QMS processes including good documentation practices (GDP/ALCOA+), and ZenQMS workflows; serve as the internal subject matter expert for quality system tools.
Manage the end-to-end NC/CAPA lifecycle.
Administer the Change Control program, reviewing proposed changes for quality and regulatory impact, coordinating cross-functional approvals, and ensuring traceability.
Maintain and report on key quality metrics: NC aging, CAPA on-time closure rate, overdue change controls — escalating trends to the Head of Quality.
Support MLI’s 21 CFR Part 11 and EU Annex 11 compliance posture — including audit trail reviews, access control oversight, and periodic data integrity assessments.
Maintain and operationalize the Data Integrity Policy program, including DI risk mapping methodology and audit trail review schedules.
Identify compliance gaps and drive remediation through the QMS; contribute to regulatory readiness and customer audit preparation.
Plan, lead, and execute internal quality audits across MLI’s QMS programs, operations, and facilities; document findings and drive timely CAPA closure in ZenQMS.
Conduct supplier audits (on-site and remote) as part of MLI’s supplier management program.
Support/host for external audits and regulatory inspections — including customer quality audits, partner assessments, and regulatory agency visits.
Maintain the annual audit schedule and audit program metrics.
Administer MLI’s supplier qualification and ASL program — coordinating supplier questionnaires, risk tiering, and qualification records.
Assist with quality agreement reviews and supplier change notifications as needed.
Coordinate and support the annual Management Review process — compiling quality metrics, preparing input reports, and maintaining review records in ZenQMS.
Generate periodic quality performance dashboards and trend reports for the Head of Quality and senior leadership.
Perform other activities as required in support of the quality department.

Requirements

Bachelor’s degree in Life Sciences, Engineering, Chemistry, or a related field.
6-8 years of quality systems or GxP compliance experience in CGT, biopharma, medical device, or contract development/manufacturing.
Demonstrated hands-on experience administering an eQMS platform (ZenQMS, Veeva, MasterControl, or equivalent).
Strong working knowledge of 21 CFR Part 11, EU Annex 11, ALCOA+, and GDocP principles.
Experience conducting internal and/or supplier audits in a regulated GxP environment; familiarity with ISO 9001, ISO13485 or ISO 19011.
Experience hosting or supporting external audits or regulatory inspections (customer audits, FDA, EMA, Notified Body, or equivalent).
Experience owning quality program execution — not just supporting it — in a small or fast-moving team environment.
Excellent technical writing and documentation skills with meticulous attention to detail.
Comfortable operating with autonomy and building process where limited infrastructure exists.
Direct experience with eQMS configuration and administration.
Lead auditor certification (ISO 9001, ISO 13485, or equivalent).
Background in equipment or software validation (IQ/OQ/PQ, CSV) in a GMP setting.
Familiarity with robotic or automated manufacturing systems and associated quality challenges.
ASQ CQA, CQE, or equivalent quality certification.
Prior experience in a start-up or scale-up biotech company; comfort with ambiguity and rapid iteration.

Skills

ZenQMS
21 CFR Part 11
EU Annex 11
ALCOA+
GDocP
ISO 9001
ISO13485
ISO 19011
Technical writing
Documentation
Attention to detail
Autonomy
Process building
eQMS configuration
eQMS administration
Lead auditor
Equipment validation
Software validation
IQ/OQ/PQ
CSV
GMP
Robotic manufacturing systems
Automated manufacturing systems
ASQ CQA
ASQ CQE

Location

San Francisco, CA

Work Type

Onsite
Domestic travel
International travel

Experience Level

Staff
6-8 years

Education Level

Bachelor's degree

Salary/Compensations

$140,000 - $185,000

Benefits

Meaningful early-stage equity
Premium Medical, Dental, and Vision plans with subsidies for child dependents
401(k) with a 4% company match
Pre-Tax Commuter Benefit
Robust Paid Parental Leave
Flexible PTO
12 Paid Holidays
Catered team lunches
Stocked kitchen
Frequent team events
H-1B and Green Card sponsorship
Referral bonuses

About the Company

Multiply Labs is a robotics company on a mission to solve a significant bottleneck in modern medicine: the manufacturing of life-saving advanced biologics, from gene and cell therapies to antibodies and more.
The future of biomanufacturing is robotic—closed, automated, and scalable—ensuring critical therapeutics are accessible to every patient who needs them.
Our technology enables biopharma companies to scale production without redesigning their science, reducing regulatory hurdles and lowering costs so these treatments can reach more patients.
The Mission: Build the world’s best robots to make life-saving therapies accessible to all.
The Technology: Advanced robotic orchestration, high-precision automation, cloud-integrated hardware-software systems, dextrous manipulation, and imitation learning.
Supported by premier investors, including Casdin Capital, Lux Capital, and Y Combinator.
Headquartered in San Francisco’s vibrant Dogpatch neighborhood.

Equal Opportunity

We actively seek candidates with diverse perspectives and lived experiences. We’re committed to building a team where everyone feels valued, respected, and empowered to do their best work.
Multiply Labs encourages candidates from all backgrounds to apply — even if you don’t meet every qualification. If you’re excited about our mission and think you can contribute, we’d love to hear from you.