Quality Engineer
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Job Description
Quality Engineer managing GxP quality events, investigations, and CAPA processes. Improving Suvoda’s clinical technology quality management system through audits, KPIs, and documentation.
Responsibilities:
- 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
Requirements:
- 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
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