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, 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 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