Senior Engineer Quality & Compliance

ACG World; Satara; Sur place; INR 1 500 000 - 2 300 000; Plein temps

Résumé du poste

ACG World is seeking a seasoned QA/QC Leader to head the inhouse QA/QC team in Satara. You will prioritize inspections, guide IPQC, and ensure quality across sub-assembly and final assembly stages.

The role requires hands-on QA/QC testing, calibration, and CAPA-driven improvements with strong documentation practices. You will develop and maintain ISO and cGMP compliant quality systems, lead internal audits, support external audits, and drive continuous improvement initiatives across Production,

Qualifications

• BE/BTech in Mechanical or Industrial Engineering (or equivalent) required.
• 5-7 years in inhouse quality in a regulated industry.
• Experience with ISO, cGMP, audits and documentation.

Responsabilités

• Lead inhouse QA & QC team for daily quality assurance and control.
• Oversee dimensional, visual and functional inspection during sub-assembly and final assembly.
• Develop, implement and monitor ISO and GMP compliant quality systems.
• Review QA/QC documentation including SOPs, protocols and reports.
• Coordinate internal and external audits and calibration/validation of instruments.

Connaissances

QA/QC leadership

ISO & GMP

CAPA & FMEA

Root cause analysis

Documentation

Audit management

Calibration & Validation

Cross-functional coordination

Formation

BE/BTech in Mechanical/Industrial Engineering

Outils

Data Analysis Tools

Description du poste

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

• 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