The Project Quality Engineer is responsible for providing quality engineering support throughout the product lifecycle, including new product development, design changes, manufacturing transfers, and supplier changes. The role partners closely with R&D;, AME, Supply Chain, and Manufacturing to ensure products meet quality, safety, and regulatory requirements in accordance with Ambu's established QMS.

Responsibilities and Essential Functions:
- Ensure compliance with Design Controls and applicable regulatory requirements.
- Develop and implement project-specific quality plans and procedures to ensure adherence to quality management system, standards and regulations.
- Collaborate with project teams to review and approve design change requests (DCR) and associated quality activity plans (QAP), including required project deliverables documentation.
- Review and approve validation documentation (including validation plans, protocols and summary reports) to ensure compliance with applicable requirements.




- Responsible for risk management activities and ensuring risk documentation are reviewed and updated, as needed.
- Monitor and evaluate project performance metrics to identify areas for improvement and implement corrective actions.
- Conduct root cause analysis and implement corrective and preventive actions to address quality issues and prevent recurrence.
- Ensure proper documentation and traceability of quality records, including non-conformance reports, inspection reports, and corrective action reports.
- Train project team members on quality standards, processes, and procedures to promote a culture of quality throughout the projects.
- Support transfer of products from development to manufacturing, ensuring processes, quality controls, and documentation are established prior to release.
- Participate in project meetings and provide regular updates on quality performance and improvement initiatives.
- Stay updated with industry trends, regulations, and best practice

📌 Project Quality Engineer (México)
🏢 Ambu A/S
📍 México