Quality Engineer II, Medical Devices & Regulatory

Boston Scientific; Galway; On-site; EUR 60,000 - 75,000; Full time

Job summary

Boston Scientific is seeking a Quality Engineer II on a 12-month fixed-term basis to ensure quality and regulatory compliance across project lifecycles. You will lead quality activities, coordinate CAPA, and investigate nonconformances, driving corrective actions and risk-based decisions.

The role requires at least 5 years in a highly regulated environment, with strong knowledge of QSR/ISO/MDD standards and proficiency in statistical tools.

Qualifications

• Level 8 Hons Bachelor Degree (or higher) in Engineering or related field.
• Minimum of 5 years' relevant experience, ideally in medical devices or regulated environments.
• Experience with nonconformance investigations, CAPA, complaint investigations, risk management and change control.
• Knowledge of QSR and ISO/MDD standards.
• Experience applying statistical tools for sampling, capability analysis, trend analysis and control charts.
• Experience supporting new product or technology transfers.

Responsibilities

• Lead quality for projects and serve as site Quality Catch/WSVA representative.
• Identify and drive corrective actions to prevent recurrence of issues.
• Review complaint signals and complete investigations for events and trends.
• Apply statistical tools to analyze data and inform decisions.
• Support change control for work instructions, protocols and reports.
• Collaborate cross-functionally to uphold patient safety and regulatory compliance.

Skills

Quality Assurance

CAPA

Risk Management

Nonconformance Investigations

Statistical Tools

Regulatory Compliance

Quality System Knowledge

Education

Engineering Degree (Level 8)

Tools

QMS

Change Control System

Quality Catch / WSVA

Job description

Boston Scientific is seeking a Quality Engineer II on a 12-month fixed-term basis to ensure quality and regulatory compliance across project lifecycles. You will lead quality activities, coordinate CAPA, and investigate nonconformances, driving corrective actions and risk-based decisions.

The role requires at least 5 years in a highly regulated environment, with strong knowledge of QSR/ISO/MDD standards and proficiency in statistical tools.