Quality Engineer, Medical Devices — Drive Process Excellence

BD Mexico; Reynosa; On-site; MXN 240,000 - 360,000; Full time

Job summary

BD Mexico is seeking an Engineer to support quality processes in Reynosa. The role focuses on root cause analysis, CAPA, and process transfers within a medical device environment, ensuring compliance with GMP/ISO standards and risk management practices.

The candidate will collaborate with corporate teams to clarify designs, monitor manufacturing documentation, and investigate quality issues using DOE/ANOVA techniques. Strong communication and bilingual skills are preferred.

Qualifications

• Bachelor’s degree in engineering or equivalent.
• 2 years of experience, medical device preferred.
• Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Efficiency Verification.
• Strong working knowledge of statistical quality tools and SPC.
• Strong working knowledge of QSR, ISO, MDD/MDR, Risk Management, and Canadian Medical Device requirements preferred.
• Demonstrate effective communication, presentation and influencing skills, bilingual English and Spanish (preferred).

Responsibilities

• Interact with corporate and divisional personnel to clarify specifications, product design changes, quality issues and technology transfers.
• Lead the product and process transfer; responsible to meet the transfer due date, smooth transfer without major quality issues.
• Responsible for developing and maintaining the quality and monitoring the manufacturing documentation to comply with our standards.
• Support the Quality Engineer Manager and Quality Manager in the budget activities.
• Investigates the root cause of quality problems and complaints using statistical techniques (DOE, ANOVA, Regression Analysis, etc.).
• Improve manufacturing, inspection, and test documentation to ensure that customer requirements are met.
• Ensure GMP regulations and ISO and corporate guidelines are followed.
• Responsible for the technical Supervisor on the In-Process Inspection of their assigned lines.
• Responsible for analyzing areas of opportunities (NC) for their areas and assure that the action taken is to focus on root cause and proposing new methods to improve manufacturing process.
• Evaluate customer complaints received from Divisions.
• Responsible for opening of Quality Events
• Identify areas of opportunity within the facility.
• Identify and implement cost Improvement project and quality system improvements.
• Assist in conducting quality audits to ensure compliance with BD procedures and specifications.
• Participate in third party audits such as corporate, ISO and FDA.
• Design methods and procedures to improve inspection and testing for manufacturing and engineering.
• Perform other duties as assigned by management.
• Identify and Implement Poka-yokes on their Assigned lines to reduce Inspection on the process and Improve processes on the manufacturing lines.
• Perform Process Failure Mode Effect Analysis (PFMEA) and maintain the risk management program to ensure compliance with local and global procedure

Skills

Root Cause Analysis

Corrective Action

Preventive Action

Statistical Process Control

Quality Regulations

Bilingual English/Spanish

Education

Bachelor’s degree in engineering or equivalent

Tools

DOE

ANOVA

Regression Analysis

Job description

BD Mexico is seeking an Engineer to support quality processes in Reynosa. The role focuses on root cause analysis, CAPA, and process transfers within a medical device environment, ensuring compliance with GMP/ISO standards and risk management practices.

The candidate will collaborate with corporate teams to clarify designs, monitor manufacturing documentation, and investigate quality issues using DOE/ANOVA techniques. Strong communication and bilingual skills are preferred.