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.

• Advanced knowledge of dimensional, visual, and functional inspection during sub-assembly and final assembly.

• 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, RD, 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

Competency

Competency

Knowledge of QA/QC systems, ISO, cGMP, and regulatory requirements

Data Analysis Tools

Leadership, team/Resource management, and training ability

Identify areas for improvement in processes and implement innovative solutions.

Strong documentation, audit handling, and reporting skills

Planning and Execution

Hands-on experience in QC testing, calibration, and validation

Decision Making

Proficiency in root cause analysis, risk assessment, CAPA

Level of Education

BE/BTech in Engineering (Mechanical/ Industrial) or equivalent

BE/BTech in Engineering (Mechanical/ Industrial) or equivalent

Experience

5-7 years of experience in Inhouse in a regulated industry

5-10 years of experience in Inhouse Quality