Staff Quality Systems & Compliance Engineer

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. Reporting to the Head of Quality, this individual will be the operational owner of ZenQMS — MLI’s eQMS — and will lead day-to-day execution across all quality system programs including, but not limited to: document control, deviations/discrepancies, CAPA, change control, complaints, supplier quality, audits, data integrity, and management review.

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

Quality Systems

- 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.

Non-Conformance, CAPA & Change Control

- 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.

Compliance & Data Integrity

- 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.

Audits & Inspection Management

- 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

Supplier Quality

- 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.

Management Review & Quality Reporting

- 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.

Other activities as required in support of the quality department.

Qualifications

- 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.

Additional Preferred Qualifications

- 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.

Perks & Benefits

Total Rewards & Life at Multiply Labs

- Competitive Compensation: Salary range of $140,000 - $185,000 plus meaningful early-stage equity. We want our team to have a real stake in the future we’re building.

- Premium Health: Premium Medical, Dental, and Vision plans with subsidies for child dependents.

- Wealth Building: 401(k) with a 4% company match to help you plan for the long term.

- Pre-Tax Commuter Benefit. Pay for eligible transit and parking with pre-tax dollars to save on commuting costs.

- Parental Support: Robust Paid Parental Leave to support your family’s newest additions.

- True Flexibility: We offer Flexible PTO and 12 Paid Holidays , trusting you to manage your time and recharge when you need it.

- No Set Hours: Set your own schedule in alignment with your manager and team. We hold a high bar, measuring success by impact and outcomes – not hours logged.

- Office Perks: A vibrant SF office culture featuring catered team lunches , stocked kitchen, and frequent team events.

- H-1B and Green Card sponsorship available for exceptional talent.

- Referral bonuses for helping us build a world-class team.

- Great people, meaningful work , and a team that genuinely believes in what we're building .

Come build the world’s best robots—and help make life-saving therapies accessible to all.