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.

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.