Quality Engineer

• Manage and facilitate all stages of the Quality Event Management process, including incident/issue investigations, risk/impact assessments, trend analyses, corrective and preventive actions, and effectiveness checks
• Conduct Quality Event Investigations, facilitate root cause analyses, apply RCA tools, and develop corrective and preventive action plans in a GCP-regulated environment
• Perform quality event trend reviews and analyses, escalating observations as warranted by the QMS process
• Produce client-facing Quality Event Investigation Reports and communicate investigation progress to stakeholders
• Conduct risk assessments and facilitate impact analyses
• Attend weekly Issue Management Team meetings, prepare slides, take notes, and follow up on actions
• Prepare and evaluate quality-event data for audits and audit findings, and implement process improvements cross-functionally
• Develop and maintain KPIs to support continuous improvement of the quality management system
• Develop, review, and revise SOPs, Work Instructions, Guidelines, Forms, Templates, and knowledgebase articles
• Create internal stakeholder reports using Excel and PowerPoint on product/process performance and Quality Event Investigation status

• Bachelor’s degree in science-related field preferred
• High-achieving personality
• Desire to learn, grow, and develop
• Strong work ethic and sense of ownership
• Highly analytical with fine attention to detail
• Proactive attitude
• Strong time management and organization skills
• Ability to practice risk-based judgement
• Excellent oral and written communication skills and technical writing capabilities
• Proficient in English
• Knowledge of Process Improvement techniques preferred
• 1–3 years of experience in a GxP compliance and/or quality-related role preferred