Quality Engineer

Job not on LinkedIn

🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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Logo of Suvoda

Suvoda

501 - 1000 employees

🏥 Healthcare

📦 Logistics

💼 Consulting

💰 $40M Venture Round on 2019-12

Healthcare • Logistics • Consulting

Suvoda is a company specializing in delivering cutting-edge software solutions for managing complex clinical trials. It offers a single platform with products such as eConsent, Interactive Response Technology (IRT), electronic Clinical Outcome Assessment (eCOA), and ePatient, designed to streamline and enhance the efficiency of life-sustaining clinical studies, especially those in therapeutic areas like oncology and rare diseases. With their technology, they aim to provide full command over time-sensitive patient interactions and assist clinical trials in handling infinite variables and constant changes, ensuring high standards and effective patient consent management across various age groups to improve trial outcomes. Suvoda emphasizes collaboration with clients throughout the lifespan of a trial to maintain quality and success.

📋 Description

• 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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