Operations and Quality Engineer, Sustained Engineering

About the role

You own the quality and operational backbone for AISF deployments across sites. You design lightweight governance while enforcing traceability and readiness. You drive problem solving with engineering, robotics, and manufacturing teams. You keep audits calm and performance consistent without slowing delivery. You establish and evolve quality management systems, CMMS, PLM, and operational standards that allow AISFs to scale reliably across geographies and deployments. You embed continuous improvement into engineering workflows and lead teams through rigorous root-cause analysis and corrective action discipline. You serve as the operational and quality authority ensuring audit readiness, traceability, and performance consistency.

What you will do

You will establish and evolve quality management systems, CMMS, PLM, and operational standards that allow AISF deployments to scale reliably across geographies and deployments. You will embed continuous improvement into engineering workflows and lead teams through rigorous root-cause analysis and corrective action discipline. You will serve as the operational and quality authority ensuring audit readiness, traceability, and performance consistency. You will support the operationalization of Arena PLM or equivalent platforms for AISF bill-of-materials, part numbering, and engineering change control. You will own the Engineering Change Management process end to end, driving Engineering Change Orders and Engineering Change Requests from initiation through review, approval, implementation, and closure. You will maintain release structure, design documentation, and deployment baselines to ensure every AISF deployment is traceable to an engineering release. You will define and maintain operational lineage, tracking which hardware, software, and firmware versions are deployed at which sites and why. You will support commissioning, FAT/SAT documentation, and handoff records with regulatory-grade rigor. You will build scalable quality templates and workflows that engineering teams find useful, not burdensome. You will partner with Engineering, Robotics, Software, Manufacturing, and Facilities to define shared standards for operational readiness, quality gate criteria, and deployment workflows. You will lead risk and reliability practices, facilitating Failure Modes and Effects Analysis across design and process, and translating findings into actionable mitigations. You will develop and maintain Control Plans that link critical characteristics, process controls, inspection methods, and reaction plans to design and quality requirements.

You will lead standards definition for design reviews, safety compliance, manufacturing readiness, and operational handoff. You will build operational templates for engineering change requests, deployment checklists, and incident response. You will serve as the quality authority in technical forums and own escalation paths for quality-critical decisions. You will maintain quality metrics and trending, including first-pass yield, escape rates, CAPA effectiveness, cycle time, and deployment readiness. You will prepare audit-ready documentation and compliance evidence for regulatory bodies, customers, and internal stakeholders. You will define and maintain quality KPIs aligned with business growth and deployment scale. You will lead internal quality audits and prepare corrective action plans for any findings.

Requirements

You bring hands-on expertise building or scaling ISO 9000 aligned quality systems, with strong document control and audit readiness. You demonstrate deep skill in leading root cause analysis and driving corrective action programs to closure. You can define control plans, link critical characteristics to process steps, and maintain operational lineage. You have experience in hardware, manufacturing, or complex systems environments such as automotive, medical device, aerospace, robotics, semiconductor, or industrial equipment. You partner across functions to set standards and quality gates. You own release structures, deployment baselines, and change management so every installation is traceable. You maintain quality metrics, audit evidence, and compliance documentation for regulators and customers.

Nice to have

Experience with Arena PLM or similar systems for bill of materials and engineering change control.

Skills & tools

Quality management system; CMMS; PLM; ISO 9000; Engineering Change Management; Firmware; Software; Hardware; Manufacturing; Robotics; Research Operations; Auditing; Document control; Control plans; FMEA; CAPA.