Senior Quality Engineer - Medical Devices | ISO 13485 Lead

Medline; Mexicali; On-site; MXN 600,000 - 900,000; Full time

Job summary

Medline is seeking a Senior Quality Engineer at its MXC site to lead quality engineering initiatives focused on continuous improvement of both sterile and non-sterile products and processes. You will coordinate CAPA activities and collaborate with QC and Manufacturing Engineering to improve quality performance.

The role requires strong leadership, effective communication, and a self-driven mindset, with extensive experience in Medical Devices and regulatory knowledge including ISO13485 and

Qualifications

• Bachelor Degree in Engineering, Manufacturing, Industrial or related fields.
• Minimum 5 years of Quality Control/Engineering experience.
• Experience in Medical Devices.
• ASQ Certification (CQE) or Six Sigma a plus.
• Internal / Lead Auditor ISO 13485:2016.
• MDSAP knowledge.
• English: 90% proficiency.
• Office Windows: Word, Excel, PowerPoint.
• Strong leadership and effective communication.
• Self-driven with solid decision making.

Responsibilities

• Lead Quality Engineering functions and drive continuous improvement for sterile and non-sterile products and processes.
• Coordinate CAPA activities and partner with QC and Manufacturing Engineering.
• Ensure compliance with regulatory standards (ISO13485, MDSAP, 21CFR Part 820 FDA).
• Participate in internal audits and support external audits as required.

Skills

Leadership

Effective communication

Self-driven

Decision making

English proficiency

Education

Bachelor's Degree in Engineering/Manufacturing/Industrial

Tools

SAP

ETQ Reliance

AS400

Job description

Medline is seeking a Senior Quality Engineer at its MXC site to lead quality engineering initiatives focused on continuous improvement of both sterile and non-sterile products and processes. You will coordinate CAPA activities and collaborate with QC and Manufacturing Engineering to improve quality performance.

The role requires strong leadership, effective communication, and a self-driven mindset, with extensive experience in Medical Devices and regulatory knowledge including ISO13485 and