ABOUT THE ROLE

We are looking for a QM Engineer – Compliance & SQM to join our Medical Production division. In this role, you will take charge of supplier quality management, execute compliance programs for the medical plants, and participate in improvement initiatives. You will work closely with internal teams, global SQM partners, and suppliers to ensure all processes comply with ISO standards, global documentation, and B. Braun quality systems.
This role requires strong attention to detail, good understanding of quality systems, and the ability to coordinate with multiple stakeholders across departments.

KEY RESPONSIBILITIES

✅ 1. Supplier Quality Management for Medical Plant

• In charge of supplier quality management program.
• Create/revise supplier quality management documentation in compliance with ISO standards and Global documentation.
• Coordinate with stakeholders to create & execute the SQM audit plan.
• Provide quality reports related to SQM subjects.
• Act as co‑trainer and provide training on supplier quality management related matters.
• Coordinate with Regional and Global SQM teams to execute SQM projects and programs.

✅ 2. Compliance Programs for Medical Plants

• Act as Change Control Coordinator.
• Execute compliance activities and provide training related to compliance subjects, including Change Control and Trackwise system if needed.
• Handle compliance programs such as audit & internal audit, DIR, CAPA, Change Control, calibration, etc.
• Create/revise SOPs regarding compliance to ensure alignment with ISO standards and Global documentation.
• Prepare documentation, join audits (internal/external), and follow up audit reports when required.
• Manage compliance activities including deviation, corrective & preventive action, concessional release, deviation permit… according to relevant SOPs.

✅ 3. GMP

• Conduct GMP training.
• Create and revise SOPs related to GMP.
• Perform GMP inspections.

✅ 4. Validation & Risk Assessment

• Plan, conduct, and follow up validation activities (DQ, IQ, OQ, PQ) in accordance with B. Braun validation SOPs.
• Act as a member of the risk assessment team.
• Create/revise SOPs related to validation & RA in compliance with ISO standards and global documentation.
• Perform validation activities according to the Master Validation Plan for production processes/equipment.
• Coordinate risk assessments with Production Engineers and ensure validation meets WHO GMP/ISO 9001 requirements.
• Participate in change control coordination, CAPA, risk management, complaint handling, and quality issues support.
• Prepare validation documentation for registration activities (if required).

✅ 5. Improvement Programs & Others

• Participate in improvement teams as required.
• Propose improvement ideas.

WORKING RELATIONSHIPS

Internal:

• QM Team, Production, QC Team, Maintenance Team, PUR Team

External:

• SQM Global, QM Global, Suppliers

QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree
• Quality background knowledge

Experience

• From 2 years of related working experience in medical, pharmacy, food and electronics manufacturing

🔧 Skills

• Full working knowledge of technical or professional field; able to propose action plans.
• Knowledge of quality management systems such as ISO 9001, ISO 13485.
• Ability to apply procedures, techniques, tools to execute tasks.
• Problem‑solving skills for moderately complex issues.