Quality Assurance Engineer

Role

Purpose:

The Quality Assurance Engineer is responsible for developing, implementing, and maintaining the quality management system’s risk management, compliance, and assurance frameworks. The role ensures that organizational processes, systems, and practices are compliant with applicable standards and regulations, and that they consistently meet quality objectives through periodic QMS audits and assessments.

• Design and implement QA strategies aligned with organizational goals and quality standards.
• Lead the creation and review of Standard Operating Procedures (SOPs) supporting the QA framework.

• Compliance processes.
• Define key performance indicator (KPI) frameworks for functional efficiency.
• Ensure continuous alignment with applicable standards (e.g., ISO, Lean).

• Collaborate with operations and support functions to ensure quality goals are embedded into processes through the targeted and planned audits.
• Support CAPA development and implementation based on audit findings, risk assessments, and process reviews.
• Communicate QA process impacts clearly to stakeholders without direct involvement in product or QC activities.

• Identify process-related risks and create mitigation plans to minimize potential nonconformities.
• Escalate significant risks and noncompliance issues to leadership with recommended solutions.

• Analyze QA performance data to measure the effectiveness of assurance activities.
• Prepare and present regular reports highlighting audit results, risks, trends, and improvement opportunities.

• Guide teams in identifying inefficiencies and implementing process improvements.
• Support a culture of data-driven decision-making through proper documentation and metric tracking.

• Minimum 5 of experience in Quality Assurance, Risk Management, Compliance.

• Strong knowledge of ISO standards (especially ISO 9001, ISO 45001, ISO 14001) and other industry-specific regulatory frameworks.
• Strong understanding of root cause analysis techniques (e.g., 5 Whys, Fishbone diagrams) and problem-solving methodologies (e.g., PDCA, DMAIC).
• Ability to develop, implement, and maintain SOPs, KPIs, and process improvement initiatives.
• Skilled in risk identification, assessment, and mitigation planning.

• Excellent communication and report-writing skills.
• Strong analytical thinking and attention to detail.
• Ability to work independently and manage multiple priorities.
• Proactive mindset in escalating risks and driving continuous improvement.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Experience with Quality Management Systems software (QMS platforms) is an advantage.