Quality Systems Engineer: CAPA, NCR & ISO 13485

Ambu A/S; Mexico; On-site; MXN 420,000 - 520,000; Full time

Job summary

Ambu A/S in Mexico is expanding its Manufacturing Site and seeks a Quality System Engineer to support CAPA, NCR, and planned deviation processes, ensuring inspection readiness and robust QMS across the site.

You will lead cross-functional quality projects, coach teams on QMS procedures, maintain records, and drive improvements while aligning with ISO 13485 and regulatory standards. English proficiency required.

Qualifications

• Bachelor's degree in a related field.
• 3+ years of relevant work experience in the medical device field.
• 1+ years of experience working in Quality Systems, preferred.
• Hands on knowledge of ISO 13485.
• Experience working in manufacturing preferred.
• Must be able to read, write and understand English.

Responsibilities

• Ensures compliance of the CAPA, NCR, and Planned Deviation processes.
• Serves as site trainer for CAPA, Nonconformances systems and Planned Deviation process.
• Provide coaching and guide teams to follow QMS processes.
• Leads quality projects with cross functional teams.
• Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner.
• Facilitates tracking and closure of Nonconformances to ensure compliance across evaluation, risk, corrections, and timeliness.

Skills

Quality Systems

ISO 13485

Manufacturing

English proficiency

Education

Bachelor's degree

Job description

Ambu A/S in Mexico is expanding its Manufacturing Site and seeks a Quality System Engineer to support CAPA, NCR, and planned deviation processes, ensuring inspection readiness and robust QMS across the site.

You will lead cross-functional quality projects, coach teams on QMS procedures, maintain records, and drive improvements while aligning with ISO 13485 and regulatory standards. English proficiency required.