MedTech Quality Engineer: Root-Cause & Process Improvement

BD; Reynosa; On-site; MXN 360,000 - 540,000; Full time

Job summary

BD Reynosa in Mexico seeks a Quality Engineer with 2 years of medical device experience to lead product and process transfers, clarify specifications with cross-functional teams, and ensure documentation aligns with GMP, ISO, and BD standards.

You will investigate root causes using DOE, ANOVA, and regression, support budget activities, and participate in internal and third-party audits, while implementing corrective actions and cost improvements.

Qualifications

• Bachelor’s degree in engineering or equivalent.
• 2 years of experience in medical devices preferred.
• Strong Root Cause Analysis, Corrective Action, Preventive Action, and Efficiency Verification skills.
• Strong working knowledge of statistical quality tools and SPC.
• Knowledge of QSR, ISO, MDD/MDR and risk management; bilingual English/Spanish preferred.

Responsibilities

• Clarify specifications, product design changes, quality issues and technology transfers with corporate and divisional personnel.
• Lead the product and process transfer; ensure on-time delivery with minimal quality issues.
• Develop and maintain manufacturing documentation to comply with BD standards.
• Support Quality Engineer Manager and Quality Manager in budget activities.
• Investigate root causes of quality problems using DOE, ANOVA, regression, etc.
• Improve inspection/test documentation to meet customer requirements.
• Ensure GMP, ISO and corporate guidelines are followed.
• Oversee in-process inspection and identify opportunities for process improvement.
• Open and manage Quality Events; participate in external audits (ISO, FDA).
• Design methods to improve inspection and testing for manufacturing and engineering.

Skills

Root Cause Analysis

Quality Improvement

Statistical Process Control

Communication Skills

CAPA

Education

Bachelor’s degree in engineering

Job description

BD Reynosa in Mexico seeks a Quality Engineer with 2 years of medical device experience to lead product and process transfers, clarify specifications with cross-functional teams, and ensure documentation aligns with GMP, ISO, and BD standards.

You will investigate root causes using DOE, ANOVA, and regression, support budget activities, and participate in internal and third-party audits, while implementing corrective actions and cost improvements.