Quality Analyst / Quality Assurance Specialist / Quality Systems Analyst

Role Overview

This position is responsible for guaranteeing the quality, uniformity, and regulatory compliance of products, services, and operational workflows by designing, deploying, and supervising quality management initiatives organization-wide. The role demands performing thorough quality evaluations, interpreting performance metrics, detecting process enhancements, and ensuring strict adherence to internal protocols, legal standards, and client requirements.

Key Responsibilities

The incumbent will work collaboratively with teams in quality assurance, operations, engineering, product management, customer service, manufacturing, and other cross-disciplinary partners to boost quality outcomes, minimize defects, and promote operational excellence. Tasks include conducting root cause analysis, supporting both internal and external audits, tracking key performance indicators (KPIs), overseeing corrective and preventive action plans (CAPA), maintaining meticulous quality records, creating quality-related reports and dashboards, and spearheading continuous improvement efforts aimed at improving product dependability, customer satisfaction, and overall organizational success.

Qualifications and Experience

• A bachelor's degree in fields such as Quality Management, Engineering, Business Administration, Industrial Engineering, Manufacturing, Operations Management, Information Systems, or related disciplines is required.
• Demonstrated background in roles associated with quality assurance, quality analysis, quality systems, quality control, regulatory compliance, operational excellence, or continuous improvement is essential.
• Comprehensive knowledge of Quality Management Systems (QMS), quality assurance techniques, process refinement, root cause analysis, CAPA, risk management, and auditing procedures is needed.
• Experience performing quality inspections, conducting internal audits, evaluating processes, managing quality reporting and documentation, handling non-conformance situations, and monitoring performance is necessary.
• Familiarity with international standards and regulatory frameworks such as ISO 9001, ISO 13485, ISO 27001, GMP, FDA regulations, IATF 16949, AS9100, or related industry-specific standards is highly advantageous.
• Proficient user of Microsoft Office tools and quality management platforms like ERP, Power BI, Tableau, Minitab, Jira, Confluence, or similar analytics and quality systems.
• Strong analytical and problem-solving capabilities with expertise in interpreting quality data, spotting trends, investigating issues, and suggesting practical corrective measures.
• Excellent communication, documentation, presentation, and stakeholder engagement skills allowing effective collaboration across multiple departments including quality, engineering, operations, manufacturing, product, and business teams.
• Experience in supplier quality management, process validation, user acceptance testing (UAT), Lean Six Sigma projects, and continuous improvement initiatives is highly desirable.
• Knowledge in statistical process control (SPC), Failure Mode and Effects Analysis (FMEA), measurement system analysis (MSA), automation, and data analytics is considered a plus.
• Certifications such as ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Improvement Associate (CQIA), Lean Six Sigma Green Belt, ISO 9001 Lead Auditor, or equivalent credentials will be beneficial.
• The ideal candidate should be proactive, detail-focused, deeply committed to quality, and driven by a passion for ongoing improvement, operational excellence, and delivering superior products and services through strong quality management systems and data-based decision-making.