Global Project Quality Engineer – Medical Devices

Ambu; Ciudad Juárez; On-site; MXN 420,000 - 660,000; Full time

Job summary

Ambu is seeking a Project Quality Engineer to provide quality engineering support throughout the product lifecycle, including new product development, design changes, and manufacturing transfers. The role collaborates with R&D, AME, Supply Chain and Manufacturing to ensure products meet quality, safety and regulatory requirements in line with Ambu's QMS.

The successful candidate will implement project-specific quality plans, manage risk and validation documentation, and drive continuous

Qualifications

• Bachelor's degree in a related field.
• 3+ years of quality engineering in the medical device industry.
• Experience in ISO 13485 and FDA-regulated environments.
• Design controls expertise.
• Risk assessment and mitigation skills.
• Familiar with project management methodologies and tools.
• Strong time and task management.
• Proficient in reading, writing and understanding English.
• Ability to travel as required for project-related activities.

Responsibilities

• Ensure compliance with Design Controls and regulatory requirements.
• Develop and implement project-specific quality plans and procedures.
• Review and approve design change requests and quality activity plans.
• Review validation documentation to ensure compliance.
• Manage risk documentation and CAPA activities.
• Monitor project performance metrics and drive improvements.
• Conduct root cause analysis and implement corrective actions.
• Ensure documentation and traceability of quality records.
• Train project teams on quality standards and processes.
• Support product transfer from development to manufacturing.
• Participate in project meetings and report on quality performance.
• Stay updated on industry trends and regulatory changes.
• Act as handler for NCRs and CAPA activities.
• Support audits as part of Internal Audit Team and during external audits.

Skills

ISO 13485 environment

FDA regulated environment

Design controls

Risk assessment / mitigation

Project management methods

Time management

English proficiency

Travel willingness

Education

Bachelor's degree in a related field

Job description

Ambu is seeking a Project Quality Engineer to provide quality engineering support throughout the product lifecycle, including new product development, design changes, and manufacturing transfers. The role collaborates with R&D, AME, Supply Chain and Manufacturing to ensure products meet quality, safety and regulatory requirements in line with Ambu's QMS.

The successful candidate will implement project-specific quality plans, manage risk and validation documentation, and drive continuous