Job Purpose:

The QMS Engineer is responsible for ensuring full compliance of manufacturing activities with Integrated Management Systems (IMS) requirements within the manufacture of medical consumables while focusing on documentation, compliance assurance, audit coordination, risk management, and continuous improvement, ensuring that manufacturing operations align with ISO standards, GMP, regulatory, and internal governance frameworks

Reports To:

Engineering Manager and Packing Manager

Supervises:

None

Key Responsibilities

Integrated Management Systems (IMS) Compliance

Implement and maintain IMS requirements related to manufacturing activities in line with:

• ISO 9001 (Quality Management)
• ISO 14001 (Environmental Management)
• ISO 45001 (Occupational Health & Safety)
• GMP and relevant medical manufacturing standards

Ensure engineering practices comply with approved SOPs, work instructions, and regulatory requirements.

Act as the engineering and packing focal point for IMS-related matters.

Engineering & Packing Documentation Control

Maintain and control manufacturing IMS documentation including:

• SOPs, work instructions, maintenance-related procedures
• Risk assessments (HIRA, JSA, HAZOP where applicable)
• Change Management
• Validation & qualification protocols
• SOP Reviews
• Deviations & Investigations

Ensure all documents are current, approved, and properly version‑controlled.

Support document update initiatives during equipment modifications or process changes.

Audit & Regulatory Support

Coordinate and support:

• Internal IMS audits
• External audits (ISO certification bodies, regulatory authorities, customer audits)

Prepare manufacturing teams for audits and inspections.

Track, document, and monitor closure of engineering and packing‑related non‑conformances, observations, and CAPAs.

Conduct periodic compliance gap assessments within the manufacturing function.

Risk, Safety & Environment

Support identification and mitigation of engineering‑related risks, including:

• Equipment safety
• Utility systems
• Chemical handling systems (latex compounding, chlorination, caustic handling)

Support environmental compliance activities related to manufacturing systems:

• Waste water Treatment Plant (ETP)
• Permissible abstraction volumes
• Permissible treated water discharge
• Environmental compliance
• Room conditions and standard air change requirement
• Environmental emissions
• Waste water parameter compliance
• Production line parameter compliance
• Equipment calibration and compliance
• Packing plant equipment
• ETO
• Stability Chambers
• Dipping lines

Promote safe work practices within engineering operations.

Change Control & Continuous Improvement

Ensure all changes follow approved procedures.

Participate in root cause analysis (RCA) of incidents, deviations, and failures.

Support continuous improvement initiatives related to:

• Compliance robustness
• Documentation effectiveness
• Audit performance
• Repetitive engineering, capacity limitation and plant failures
• Major plant bottlenecks

Assist in aligning engineering practices with best medical manufacturing standards.

IMS Performance Monitoring & Reporting

Prepare IMS compliance reports related to packing and engineering.

Track key IMS metrics:

• Audit findings
• CAPA closure rates
• Document compliance status

Provide management with periodic compliance and risk status updates.

• Implement and maintain IMS requirements related to manufacturing activities in line with ISO 9001, ISO 14001, ISO 45001, GMP and relevant medical manufacturing standards.
• Ensure engineering practices comply with approved SOPs, work instructions, and regulatory requirements.
• Act as the engineering and packing focal point for IMS-related matters.
• Maintain and control manufacturing IMS documentation including SOPs, work instructions, maintenance-related procedures, risk assessments, change management, validation & qualification protocols, SOP reviews, and deviations & investigations.
• Ensure all documents are current, approved, and properly version‑controlled.
• Support document update initiatives during equipment modifications or process changes.
• Coordinate and support internal and external IMS audits.
• Prepare manufacturing teams for audits and inspections.
• Track, document, and monitor closure of engineering and packing‑related non‑conformances, observations, and CAPAs.
• Conduct periodic compliance gap assessments within the manufacturing function.
• Support identification and mitigation of engineering‑related risks, including equipment safety, utility systems, and chemical handling systems.
• Support environmental compliance activities related to manufacturing systems.
• Promote safe work practices within engineering operations.
• Ensure all changes follow approved procedures.
• Participate in root cause analysis (RCA) of incidents, deviations, and failures.
• Support continuous improvement initiatives related to compliance robustness, documentation effectiveness, audit performance, repetitive engineering, capacity limitation and plant failures, and major plant bottlenecks.
• Assist in aligning engineering practices with best medical manufacturing standards.
• Prepare IMS compliance reports related to packing and engineering.
• Track key IMS metrics: Audit findings, CAPA closure rates, Document compliance status.
• Provide management with periodic compliance and risk status updates.