Job Title: SME – Quality Engineering

Location: Coimbatore, India

About the company:

NovintiX is a quick-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 Nextern’s manufacturing environment.

Key responsibilities:

- Assess existing quality processes, quality data sources, reporting needs and data integrity risks with Nextern 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 Nextern’s 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 Nextern’s products and processes.
- Experience with QMR/QDR reporting, eQMS, material compliance systems, ERP integrations or Power BI.

Application process / equal opportunity statement:

To apply for this position, please submit your application through job portals or by email to [email protected]. Applications received through these channels will be reviewed, and shortlisted candidates will be contacted for screening and interview rounds. Only shortlisted candidates will be contacted for further steps.

NovintiX Technologies is an equal opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, marital status, veteran status, or any other protected characteristic.

📌 SME – Quality Engineering (Coimbatore)
🏢 NovintiX
📍 Coimbatore