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 practices in quality management to ensure continuous improvement of project quality processes.

As assigned, act as a handler for nonconformance reports (NCR) and Corrective Actions/Preventive Actions (CAPA) activities to drive proper risk evaluation, investigation, and implementation of actions.

Support internal and external audits as a member of the Internal Audit Team and serve as a key quality representative during external audits, providing quality system and project-related support as required.

Authorities:

Reject implementing associated documentation change requests related to projects.

Issue NCR's, CAPA's and SCAR's, as necessary.

Qualifications:

Bachelor's degree in a related field.

3+ years of Quality Engineering experience in the medical device industry.

Required skills

Experience working within an ISO 13485 and FDA regulated environment.

Strong understanding of design controls.

Strong understanding of risk assessment and mitigation strategies.

Familiarity with project management methodologies and tools.

High level of time and task management skill.

Must be able to read, write and understand English.

Ability to travel as required for project-related activities.

Work Environment:
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.

About Ambu
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

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📌 Project Quality Engineer (Heroica Puebla de Zaragoza)
🏢 Ambu A/S
📍 Heroica Puebla de Zaragoza