Impactful AMQ Engineer for Active Medical Devices

Fresenius Medical Care; Reynosa; Hybrid; MXN 420,000 - 600,000; Full time

Job summary

Fresenius Medical Care in Reynosa, MX is seeking an Advanced Manufacturing Quality Engineer for Active Medical Devices to support product and process quality through CAPA, investigations, design transfer, risk management, and regulatory compliance.

You will collaborate with Manufacturing, Engineering, Quality, and cross‑functional teams to drive continuous improvement, PFMEA updates, and validation activities in a regulated environment.

Qualifications

• Bachelor’s degree in Electronic, Mechanical, Industrial Engineering, or related field.
• Minimum 3 years in Quality/Manufacturing Engineering in regulated environments.
• Experience in Active Medical Device manufacturing or electronics integration preferred.
• Experience with manufacturing quality investigations, root cause analysis, nonconformance, CAPA, cross-functional problem solving, and process improvements.

Responsibilities

• Provide technical Quality Engineering support to manufacturing processes for Active Medical Devices.
• Analyze manufacturing quality data and process trends to identify quality issues and improvement opportunities.
• Participate in technical walkthroughs to identify potential quality risks and improvement opportunities.
• Support cross-functional teams during quality investigations and CAPA activities.
• Assist in design transfer reviews, engineering change evaluations, and product documentation reviews.
• Support Process Validation, Test Method Validation, and MSA activities.
• Contribute to PFMEA updates and manufacturing risk assessments.

Skills

Quality Engineering

Root Cause Analysis

CAPA Investigations

Process Validation

Statistical Analysis

Minitab

Design Transfer

Risk Management

Education

Bachelor’s Degree in Electronic/Mechanical/Industrial Engineering

Tools

Minitab

ERP/MES Systems

Quality Management Software

Job description

Fresenius Medical Care in Reynosa, MX is seeking an Advanced Manufacturing Quality Engineer for Active Medical Devices to support product and process quality through CAPA, investigations, design transfer, risk management, and regulatory compliance.

You will collaborate with Manufacturing, Engineering, Quality, and cross‑functional teams to drive continuous improvement, PFMEA updates, and validation activities in a regulated environment.