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 workplace.

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.
- Strong 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 / Quality (Coimbatore)
🏢 NovintiX
📍 Coimbatore