Senior Quality Engineer

About Us

HighRes is a revolutionary laboratory automation leader committed to improving human health through life science robotics. Our technologies enable scientists to develop life-saving medicines, treatments, and therapies while maximizing resources and increasing output. At HighRes, we foster innovation, embrace diversity, and value the opportunity to hear every team member’s voice, ideas, and input, contributing to our continued success.

Job Summary

HighRes is seeking a collaborative and results-oriented Senior Quality Engineer to lead the investigation and resolution of product, process, supplier, and customer quality issues. In this role, you will lead the Corrective and Preventive Action (CAPA) process, facilitate Device Review Meetings, support customer complaint and nonconformance investigations, and drive effective corrective actions through closure.

The ideal candidate has strong experience with structured problem solving, root cause analysis, quality data, and cross-functional leadership within a complex manufacturing or automation environment. This position works closely with Engineering, Manufacturing, Systems Integration, Service, Supply Chain, Project Management, and other teams to strengthen the Quality Management System (QMS), improve product quality, and prevent recurrence.

Key Responsibilities

• Lead the CAPA process from initiation through closure, including problem definition, containment, investigation, root cause analysis, action planning, implementation, effectiveness verification, and documentation.
• Facilitate Device Review Meetings and other cross-functional quality forums by guiding quality and risk discussions, documenting decisions, tracking actions, and driving timely resolution.
• Partner with Engineering, Manufacturing, Systems Integration, Service, Supply Chain, Project Management, and other functions to investigate customer complaints, product nonconformances, field issues, and process failures.
• Apply structured problem-solving and root cause analysis methods, including 5 Whys, fishbone analysis, fault-tree analysis, Pareto analysis, and 8D, to identify systemic causes and prevent recurrence.
• Evaluate nonconforming material and product issues, support Material Review Board (MRB) activities, assess product and customer risk, and provide evidence-based recommendations for disposition and escalation.
• Develop, implement, and verify corrective actions that address both the immediate issue and the underlying process or system weakness.
• Maintain and improve the QMS by supporting document and process improvements, internal audits, management review inputs, training, and compliance with approved procedures.
• Monitor quality performance indicators, identify adverse trends and recurring failure modes, and lead data-driven continuous improvement initiatives.
• Support supplier quality activities, including supplier corrective actions, investigation of supplier-related defects, review of supplier responses, and verification of corrective action effectiveness.
• Support internal, customer, and certification audits by preparing objective evidence, explaining quality processes, and ensuring timely closure of assigned actions.
• Provide quality engineering guidance to project teams throughout design, build, test, release, installation, and post-delivery support, with an emphasis on risk identification and prevention.
• Coach and mentor employees on quality requirements, investigation techniques, root cause analysis, CAPA expectations, and effective problem solving.