Operations and Quality Engineer, Sustained Engineering

We're seeking an Operations & Quality Engineer to establish and evolve the quality management systems (QMS), CMMS, PLM, operational standards, and continuous improvement infrastructure required to scale AISFs reliably across geographies and deployments. This role will drive quality culture, operational rigor, and systemic problem-solving across Engineering, Robotics, Software, Manufacturing, and Research Operations.

Unlike traditional quality administration, this position focuses on building lightweight but defensible quality systems, embedding continuous improvement into the engineering workflow, and leading teams through root-cause analysis and corrective action discipline. You'll be the operational and quality authority that ensures AISF deployments maintain audit readiness, traceability, and performance consistency while preserving engineering velocity.

• Establish and maintain an ISO 9000 aligned QMS framework tailored to hardware-software-operations environments
• Own quality policy, operational procedures, document control, and record retention across the AISF platform lifecycle
• Define audit-ready traceability and configuration control standards for engineering changes, deployments, and operational baselines
• Build scalable quality templates and workflows that engineering teams want to use, not resent
• Ensure QMS evolves with organizational growth—lightweight early, rigorous at scale

• Support operationalization of Arena PLM (or equivalent) for AISF bill-of-materials, part numbering, and engineering change control
• Own the Engineering Change Management (ECM) process end to end—drive Engineering Change Orders (ECOs) and Engineering Change Requests (ECRs) from initiation through review, approval, implementation, and closure
• Own release structure, design documentation, and deployment baselines to ensure every AISF deployment is traceable to an engineering release
• Maintain operational lineage: which hardware, software, and firmware versions are deployed at which sites, and why
• Support commissioning, FAT/SAT documentation, and handoff records with regulatory-grade rigor

• Partner with Engineering, Robotics, Software, Manufacturing, and Facilities to define shared standards for operational readiness, quality gate criteria, and deployment workflows
• Lead risk and reliability practices: facilitate Failure Modes and Effects Analysis (FMEA) across design and process, and translate findings into actionable mitigations
• Develop and maintain Control Plans that link critical characteristics, process controls, inspection methods, and reaction plans to design and quality requirements
• Lead standards definition for: design reviews, safety compliance, manufacturing readiness, and operational handoff
• Build operational templates for engineering change requests, deployment checklists, and incident response
• Serve as the quality authority in technical forums; own escalation paths for quality-critical decisions

• Maintain quality metrics and trending: first-pass yield, escape rates, CAPA effectiveness, cycle time, and deployment readiness
• Prepare audit-ready documentation and compliance evidence for regulatory bodies, customers, and internal stakeholders
• Define and maintain quality KPIs aligned with business growth and deployment scale
• Lead internal quality audits; prepare corrective action plans for any findings

• 3+ years in quality, operations, or engineering roles in hardware, manufacturing, or complex systems environments (automotive, medical device, aerospace, robotics, semiconductor, or industrial equipment)
• Hands-on expertise building or scaling ISO 9000 compliant quality systems—you understand document control, procedure discipline, and audit readiness
• Demonstrated experience leading RCA investigations and CAPA programs—you've driven teams through root-cause discipline, tracked corrective actions to closure, and verified effectiveness
• Comfort with Arena PLM, Windchill, SAP PLM, or equivalent lifecycle management systems—you understand part numbering, bill-of-materials rigor, and design change control
• Hands-on experience running Engineering Change Management (ECM)—you've owned ECO/ECR workflows from initiation through implementation and closure
• Experience developing FMEAs and Control Plans—you can lead cross-functional risk assessments and translate them into concrete process controls and reaction plans
• Track record building operational templates, procedures, and workflow standards that teams actually adopt
• Strong cross-functional leadership skills—you communicate with engineers, operators, finance, and executives without losing precision

• Experience supporting robotics, automation, advanced manufacturing, hardware infrastructure, or technical operations environments.
• Familiarity with commissioning, FAT/SAT, sustaining engineering, deployment readiness, or operational support workflows.
• Exposure to operational governance, engineering standards, or lightweight quality systems in technical organizations.
• Experience building templates, operational workflows, onboarding structures, or lifecycle coordination systems.

• Systems-minded operator: You see quality not as a bottleneck, but as an enabler of speed and confidence
• Bias toward lightweight rigor: You reject bureaucracy but embrace discipline where it matters (safety, traceability, learning)
• Continuous improvement mindset: You drive Kaizen-style incremental improvements; you're comfortable with emerging processes and willing to iterate
• Escalation discipline: You know when to escalate, when to solve, and how to maintain follow-through without constant hand-holding
• Calm under complexity: You operate confidently in multidisciplinary environments and evolving organizational structures
• Hands-on contributor: You don't just set policy—you participate in RCA investigations, commissioning activities, and operational troubleshooting

• Experience with failure modes analysis (FMEA), design reviews, or safety-critical system assessment
• Familiarity with PLM workflows, CAD/PDM systems, or version control in hardware engineering contexts
• Understanding of manufacturing readiness, sustaining engineering, or deployment support workflows
• Experience with commissioning, FAT/SAT (Factory Acceptance Testing / Site Acceptance Testing), or operational handoff in hardware environments
• Knowledge of quality frameworks beyond ISO 9000 (e.g., IATF 16949, FDA QMS, safety standards)

Lila Sciences is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

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