ABOUT THE ROLE

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

KEY RESPONSIBILITIES

1. Supplier Qualification Management – Medical Plant

• Take charge of the supplier qualification management program.
• Prepare and maintain supplier qualification documentation in compliance with ISO standards and global documentation.
• Coordinate with stakeholders to execute the SQM audit program.
• Consolidate and report supplier-related SQM activities.
• 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 internal applications used for handling and recording issues.
• Ensure compliance with procedures such as DMR, CAPA, Change Control, calibration, etc.
• Create SOPs regarding compliance to ensure alignment with ISO standards and global documentation.
• Consolidate compliance data, prepare reports, analyze issues, and propose corrective and preventive actions.
• Support internal and external audits.
• Ensure deviation reports, concession releases, and preventive actions are handled according to relevant SOPs.

QUALIFICATIONS

Education

• Bachelor’s degree in Engineering, Quality Management, or related field.

Experience

• Experience in Quality Management, Compliance, or Supplier Quality is preferred.
• Experience in a manufacturing environment, ideally medical device or pharmaceutical, is an advantage.

Skills

• Intermediate English level (reading and writing compliance documents, internal communication).
• Strong analytical and problem‑solving skills.
• Good communication and coordination skills.
• Ability to work cross‑functionally and manage multiple tasks.
• Familiarity with ISO standards and compliance systems.