Quality Engineer (Systems & Compliance)

Role overview Support the quality, reliability, and performance of regulated products by coordinating investigations into quality events and improving the processes used to manage them. The work combines root cause analysis, risk assessment, corrective and preventive action tracking, audit support, and clear reporting for both technical teams and external stakeholders.

Responsibilities - Coordinate quality event investigations from initial review through risk assessment, trend analysis, corrective and preventive actions, and effectiveness checks. - Facilitate root cause analysis with cross-functional teams, using structured methods to assess evidence and define appropriate actions in a GCP-regulated environment. - Review quality event trends and escalate findings through the quality management process. - Prepare investigation reports and stakeholder updates, translating technical findings for non-technical audiences. - Support audits and audit responses with quality event data, and help teams implement process improvements. - Maintain quality KPIs, prepare internal reports, and develop or update procedures, work instructions, forms, and related guidance.

Requirements - Strong analytical skills, attention to detail, organization, and time management. - Ability to apply risk-based judgment and take ownership of investigation and improvement work. - Excellent written and verbal communication skills, including technical writing; English proficiency is required. - One to three years of experience in a GxP compliance or quality-related role is preferred. - A bachelor’s degree in a science-related field is preferred. - Interest in learning and developing, with a proactive approach and a strong work ethic.

Nice to have - Knowledge of process improvement methods.