MedTech Quality Engineer: Process Transfer & RCA

Becton Dickinson; Reynosa; On-site; MXN 240,000 - 360,000; Full time

Job summary

Becton, Dickinson, and Company is seeking a QA Engineer for our Reynosa facility. The role emphasizes root-cause analysis, corrective actions, and robust QA processes to ensure GMP and ISO compliance across manufacturing lines.

Candidate should hold a Bachelor’s in engineering or equivalent with at least 2 years in medical devices. English and Spanish bilingualism is preferred as part of cross-functional collaboration.

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.
• 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; meet the transfer due date with minimal quality issues.
• Develop and maintain quality and manufacturing documentation to comply with standards.
• Support the Quality Engineer Manager and Quality Manager in budget activities.
• Investigate root causes of quality problems using DOE, ANOVA, Regression Analysis, etc.
• Improve inspection, testing, and documentation to meet customer requirements.
• Ensure GMP, ISO, and corporate guidelines are followed.
• Oversee In-Process Inspection on assigned lines.
• Identify opportunities (NC) and implement corrective actions focusing on root cause.
• Evaluate customer complaints and perform Quality Events.
• Design methods to improve inspection and testing for manufacturing and engineering.
• Participate in third party audits (ISO, FDA).
• Perform PFMEA and maintain risk management program.

Skills

Root Cause Analysis

Corrective Action

Preventive Action

SPC

QSR/ISO/MDD/MDR knowledge

Risk Management

Bilingual English/Spanish

Education

Bachelor’s degree in engineering or equivalent

Tools

DOE

ANOVA

Regression Analysis

Job description

Becton, Dickinson, and Company is seeking a QA Engineer for our Reynosa facility. The role emphasizes root-cause analysis, corrective actions, and robust QA processes to ensure GMP and ISO compliance across manufacturing lines.

Candidate should hold a Bachelor’s in engineering or equivalent with at least 2 years in medical devices. English and Spanish bilingualism is preferred as part of cross-functional collaboration.