Job Title: SME – Quality Engineering

Location:
Coimbatore, India

About the company
NovintiX is a fast-growing engineering and digital transformation company serving top Life Sciences, MedTech, and Healthcare clients across the US, Ireland, and Europe. We specialise in delivering high-impact digital programs, engineering services, and talent solutions that accelerate innovation, efficiency, and compliance. Role overview: Provide senior quality engineering expertise to define, validate and improve quality data processes, material compliance workflows and quality analytics for manufacturing environment.

Key responsibilities
• Assess existing quality processes, quality data sources, reporting needs and data integrity risks with stakeholders.
• Define requirements and business rules for quality data processing and QMR/QDR reporting, including data definitions, metrics, trends and exception handling.
• Support analysis of nonconformances, deviations, CAPA, complaints, audit findings or other quality records where included in the agreed scope.
• Support material compliance data management, including required attributes, evidence/documentation, status tracking and reporting needs.
• Define data quality checks, traceability requirements, review controls and approval expectations for quality-related reporting.
• Work with Data Engineers and the Data Architect to map quality data sources, validate transformations and ensure dashboard metrics align with approved definitions.




• Review quality trends and indicators and translate them into actionable insights for quality and operations leadership.
• Support requirements, test scenarios, UAT, work instructions and knowledge transfer for quality data processing and digital automation.
• Ensure proposed workflows and reports align with applicable quality procedures and regulatory obligations; escalate items requiring Quality/Regulatory approval. Required

experience:
• Relevant

experience:
10+ years of relevant experience.
• Educational

qualifications:
Bachelor’s degree in quality engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Life Sciences, or a related discipline. Additional training or certification in quality systems, auditing or risk management is beneficial.
• 10+ years in Quality Engineering, Quality Systems, Manufacturing Quality or related roles.
• Strong knowledge of quality data, nonconformance/deviation handling, CAPA, audit readiness and quality metrics.
• Experience with quality investigations, trend analysis, data review and cross-functional problem-solving.
• Ability to define data requirements, validation rules, traceability and review/approval controls.
• Solid documentation, communication and stakeholder management skills. Preferred

qualifications:
• Medical device or other regulated-industry experience.
• Knowledge of ISO 13485, risk management and applicable regulatory quality-system requirements, where relevant to products and processes.
• Experience with QMR/QDR reporting, eQMS, material compliance systems, ERP integrations or Power BI.

📌 SME – Supply Chain (Coimbatore)
🏢 NovintiX
📍 Coimbatore