Senior Engineer Quality & Compliance

Primary responsibilities -

• Lead the inhouse QA & QC team in day-to-day quality assurance and quality control activities. Prioritizes inspections and manpower based on project load.
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• Develop, implement, and monitor quality systems in compliance with ISO, GMP, and regulatory standards. Develop the QAP for new products
• Review and approve QA/QC documentation (SOPs, Protocols, Test reports, validations).
• Conduct internal audits and support external audits.
• Ensure calibration, validation, and preventive maintenance of quality instruments.
• Identifies potential failure points early in the process using FMEA and past NCR data. Drive root cause analysis, CAPA, and continuous improvement initiatives.
• Coordinate with cross-functional teams (Production, R&D, Engineering, Procurement) to resolve quality issues.
• Guides IPQC inspectors and supports Production for in-line quality assurance.
• Implementation of Kaizen & 5S activities for continual improvement.
• Takes ownership of process quality and product performance at each stage

Key Result Areas

• Zero major NCs in customer and regulatory audits.
• On-time closure of deviations, CAPA, and complaints.
• Effective functioning of inhouse QA/QC lab as per defined standards.
• Reduction in rework, rejection, and customer complaints.
• Timely preparation of MIS and quality metrics.

Technical Competency