Quality Engineer

This is a fully remote position, open to applicants in Romania.

📋 Description

• Oversee and coordinate all phases of the Quality Event Management process, which includes conducting incident/issue investigations, performing risk and impact assessments, executing trend analyses, implementing corrective and preventive actions, and verifying their effectiveness.

• Carry out Quality Event Investigations, lead root cause analyses, utilize RCA tools, and formulate corrective and preventive action plans within a GCP-regulated framework.

• Execute quality event trend reviews and analyses, escalating findings as necessary in accordance with the QMS process.

• Generate Quality Event Investigation Reports for clients and keep stakeholders informed about the progress of investigations.

• Perform risk assessments and facilitate analyses of impacts.

• Participate in weekly Issue Management Team meetings, prepare presentation slides, take notes, and follow up on action items.

• Compile and assess quality-event data for audits and audit findings, and implement cross-functional process enhancements.

• Establish and maintain KPIs to bolster the continuous improvement of the quality management system.

• Create, review, and update SOPs, Work Instructions, Guidelines, Forms, Templates, and knowledgebase articles.

• Develop internal reports for stakeholders utilizing Excel and PowerPoint to showcase product/process performance and the status of Quality Event Investigations.

⛳️ Requirements

• A bachelor’s degree in a science-related discipline is preferred.

• A high-achieving mindset.

• A strong desire to learn, develop, and advance.

• A robust work ethic accompanied by a sense of ownership.

• Highly analytical with meticulous attention to detail.

• A proactive approach to tasks.

• Strong organizational and time management skills.

• Ability to exercise risk-based judgment.

• Exceptional oral and written communication skills alongside technical writing proficiency.

• Proficient in English.

• Familiarity with Process Improvement methodologies is preferred.

• 1–3 years of experience in a GxP compliance or quality-related position is preferred.

🏝️ Benefits

• Comprehensive health benefits.

• Opportunities for professional development and growth.

• Collaborative and innovative work environment.

• Flexible work arrangements.