Senior Quality Validation Engineer, Design Transfer

BD; Tijuana; On-site; MXN 900,000 - 1,200,000; Full time

Job summary

BD is seeking a Quality Engineer to lead validation and transfer activities for design and manufacturing lines in Tijuana. You will develop strategies for qualification, drive process validation, and ensure product quality through robust controls and risk management.

Cross-functional collaboration across design, manufacturing, and regulatory teams is essential. The role emphasizes independent leadership, adherence to medical device quality standards, and the ability to deliver evidence-based

Qualifications

• Lead quality engineering and validation for transfer projects.
• Develop strategies and evidence to demonstrate manufacturing readiness.
• Apply risk-based methods to identify and mitigate quality risks.

Responsibilities

• Lead quality activities for design transfer and manufacturing line transfer.
• Develop and execute the quality and validation strategy for transfer projects.
• Lead process validation and equipment qualification activities.
• Apply risk-based methodologies throughout transfer activities.
• Ensure design outputs translate into manufacturing requirements and controls.
• Support supplier qualification and readiness for transferred products.

Skills

Quality leadership

Cross-functional teamwork

Problem solving

Regulatory awareness

Tools

Process FMEA

Design FMEA

Fault tree analysis

Risk assessments

Job description

BD is seeking a Quality Engineer to lead validation and transfer activities for design and manufacturing lines in Tijuana. You will develop strategies for qualification, drive process validation, and ensure product quality through robust controls and risk management.

Cross-functional collaboration across design, manufacturing, and regulatory teams is essential. The role emphasizes independent leadership, adherence to medical device quality standards, and the ability to deliver evidence-based