Staff Quality Engineer II - Medical Device Wearable Systems

Becton Dickinson; South Dublin; On-site; EUR 95,000 - 105,000; Full time

Job summary

BD in Dublin South seeks a Staff Quality Engineer II to lead design controls, risk management, process validation, and CAPA across wearable injector devices. You will partner with software, hardware, manufacturing, regulatory and R&D teams to support product development, validation activities, and lifecycle improvements, ensuring ISO 13485, FDA QSR compliance and high patient safety standards.

This role reports to the Senior Manager of Quality Engineering and requires strong analytical and

Qualifications

• Bachelor's degree in Engineering or related field.
• 12+ years in Quality Engineering in medical devices or pharmaceutical setting.
• Knowledge of ISO 13485, FDA QSR, GMP and design control lifecycle.
• Experience with statistical methods and quality tools.

Responsibilities

• Lead failure investigations, root cause analysis, and CAPA.
• Ensure design controls and quality standards across product lifecycle.
• Review and approve product/process/test method specifications.
• Collaborate with software, hardware, manufacturing, regulatory and R&D teams.
• Plan/execute validation, supplier qualification, and risk mitigation.
• Drive continuous improvement in product quality and performance.

Skills

Design controls

Risk management

Process validation

Root cause analysis

Measurement systems analysis

Design verification

Regulatory compliance

Cross-functional collaboration

Statistical methods

Six Sigma

FMEA

Education

Bachelor's degree in Engineering

Tools

CAPA systems

Quality Systems

Job description

BD in Dublin South seeks a Staff Quality Engineer II to lead design controls, risk management, process validation, and CAPA across wearable injector devices. You will partner with software, hardware, manufacturing, regulatory and R&D teams to support product development, validation activities, and lifecycle improvements, ensuring ISO 13485, FDA QSR compliance and high patient safety standards.

This role reports to the Senior Manager of Quality Engineering and requires strong analytical and