Quality Engineer I — Medical Devices & CAPA

Fresenius Medical Care; Reynosa; On-site; MXN 300,000 - 420,000; Full time

Benefits offered by this job

Career development

Innovative culture

Global company

Competitive benefits

Professional team

Job summary

Fresenius Medical Care, a global leader in kidney care, seeks a Quality Engineer I to support product and process quality for medical devices at the Reynosa facility. You will work with cross-functional teams across the lifecycle to ensure compliance with quality, design control, validation, risk management, and regulatory requirements.

The role requires a bachelor’s degree in engineering, 2+ years in quality engineering (medical devices preferred), proficiency with statistical tools, and

Qualifications

• Bachelor’s degree in Engineering, preferably Mechanical, Industrial, Electrical, Electromechanical, Biomedical, or equivalent.
• Minimum 2 years of experience in Quality Engineering or a related field; Medical Device experience preferred.
• Experience or knowledge in CAPA, NC, Root Cause Analysis, product/process validation, Risk Analysis, Process Capability, test methods, and statistical quality tools.
• Knowledge of DOE, Gage R&R, Correlation & Regression, Acceptance Sampling, Six Sigma, cGMP, FDA, ISO, and MDD.
• Strong technical, analytical, mathematical, problem-solving, computer, and communication skills, with the ability to present information to upper management and other groups.
• Ability to develop and implement methods and use statistical tools to identify process behavior and resolve quality issues.
• Customer-focused quality approach.
• Bilingual English / Spanish.
• U.S. Visa required.

Responsibilities

• Support customer complaints, Nonconformances (NC), CAPA, Root Cause Analysis, and corrective/preventive actions.
• Support product/process validations, test method development, specifications, design reviews, qualification, Design Controls, and Design Transfer.
• Perform statistical analysis using DOE, Correlation & Regression, Acceptance Sampling, Gage R&R, Process Capability Studies, control charts, flow charts, scatter diagrams, and histograms.
• Apply statistical inference and Binomial, Poisson, Normal, and Exponential distributions.
• Support manufacturing process, product, and quality improvements, including engineering changes, cost-saving projects, and Change Control.
• Apply Risk Management techniques throughout the product life cycle.
• Ensure compliance with applicable cGMP, FDA, ISO, and MDD requirements, including required quality/regulatory documentation, customer complaint samples, and FIRs.
• Support internal and external audits, including observations and corrective actions.
• Collaborate with internal, cross-functional, and cross-site teams on quality initiatives, while managing assigned project priorities, objectives, deliverables, and timelines.

Skills

Quality engineering

CAPA

Root cause analysis

Statistical quality tools

DOE

Gage R&R

Process capability

Six Sigma

cGMP knowledge

Bilingual English/Spanish

Communication skills

Education

Bachelor’s degree in Engineering

Job description

Fresenius Medical Care, a global leader in kidney care, seeks a Quality Engineer I to support product and process quality for medical devices at the Reynosa facility. You will work with cross-functional teams across the lifecycle to ensure compliance with quality, design control, validation, risk management, and regulatory requirements.

The role requires a bachelor’s degree in engineering, 2+ years in quality engineering (medical devices preferred), proficiency with statistical tools, and