Project Quality Engineer

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

A Global Job Position With An ImpactThe 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.

A Global Job Position With An ImpactThe 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.