Assistant Manager - QA & EHS - Manesat, Gurgaon

Purpose of Job

Responsible for establishing, implementing, and maintaining Quality Assurance and EHS systems in alignment with ISO and regulatory standards. The role ensures continual improvement in product quality, operational processes, workplace safety, and environmental sustainability at DS Facilities.
Principle Accountabilities:

Quality Assurance (QA):

• Implement and maintain Quality Management Systems (QMS) in accordance with ISO 9001:2015 and ISO 13485:2016 requirements.
• Review, monitor, and continuously improve QMS processes to ensure compliance and enhance product quality.
• Conduct regular process audits and coordinate internal and external quality audits.
• Lead CAPA (Corrective and Preventive Actions) — ensure timely investigation, verification, and closure of non-conformities.
• Coordinate with Production, QC, Stores, and Maintenance teams to resolve quality issues and prevent recurrence.
• Manage QMS software (SmartSolve) efficiently for document control, deviations, change controls, complaints, and CAPA tracking.
• Handle customer complaints, conduct root cause analysis, implement corrective actions, and communicate resolutions.
• Oversee supplier quality management — including supplier audits, incoming material inspection, and supplier performance evaluation.
• Maintain calibration, validation, and preventive maintenance schedules for all critical equipment.
• Ensure timely preparation, control, and archiving of all quality documents, reports, and records as per documentation control procedures.
• Participate in management reviews and drive continual improvement initiatives.
• Support product and process validation, line clearance, and first article inspections.
• Stay updated on relevant quality standards, regulatory changes, and best practices in medical device manufacturing.

Environment, Health & Safety (EHS):

• Implement and maintain ISO 14001:2015 (Environmental Management System) and ISO 45001:2018 (Occupational Health & Safety Management System).
• Conduct regular safety inspections, risk assessments, and hazard identification in all areas of operation.
• Develop and implement workplace safety programs, procedures, and training modules.
• Investigate accidents, near-misses, and incidents; perform root cause analysis; and ensure corrective actions are completed.
• Coordinate and lead Quarterly EHS Management Reviews and ensure continuous improvement in EHS performance.
• Ensure compliance with local statutory and regulatory requirements for environment, health, and safety.
• Oversee waste management, disposal, and environmental control measures to minimize environmental impact.
• Monitor and improve fire safety readiness, emergency response systems, and employee awareness programs.
• Conduct safety patrols and ensure timely closure of identified gaps or open points.
• Promote a culture of safety awareness, accountability, and proactive risk management across all departments.

Training & Communication:

• Conduct regular training sessions for employees on Quality Systems, Safety protocols, Emergency Response, and 5S/6S.
• Ensure effective communication of quality and safety requirements across departments.
• Act as a liaison between regulatory bodies, certification agencies, and corporate QA/EHS teams.

Education Training, Work Qualifications, Knowledge, Skills & Abilities

Essential

• Diploma or Degree in Mechanical / Chemical / Electrical / Biotech Engineering (Minimum 5 years of relevant experience).
• Certified in ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, and ISO 45001:2018 systems.
• Sound knowledge of Leaņ Management, Kaizen, CAPA, RCA, 6S, 7QC Tools, Risk Assessment, and Change Control processes.
• Exposure to Six Sigma or Lean methodologies
• Strong analytical skills with the ability to interpret quality data and identify trends.
• Hands-on experience with QMS software and documentation control systems.
• Excellent leadership, decision-making, communication, and presentation skills.
• Demonstrated ability to work cross-functionally and manage multiple priorities effectively.

Desirable
Experience in Medical Device / Pharma manufacturing environment