Quality Engineer II

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

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.Advancing possibilities for a brighter tomorrowWe are seeking a Quality Engineer II on a defined term basis (12 months) to join our team.Job Purpose:As an experienced quality professional, you will support the successful delivery of projects by ensuring quality and compliance requirements are effectively integrated throughout the project lifecycle. You will demonstrate a commitment to the Quality Policy, patient safety and product quality through the application of sound quality principles, risk-based decision-making and cross-functional collaboration.You will maintain and promote an effective quality management system, ensuring compliance with all applicable regulatory and company requirements while driving project success and upholding high standards of patient safety, product quality and regulatory complianceKey Responsibilities:Take a preventive approach to quality assurance by proactively identifying potential issues.Provide direction and support to colleagues based on subject matter expertise and Quality System knowledge.Manage and coordinate department activities as applicable, including NCEP, CAPA, PIR escalation and complaints.Serve as the quality lead for projects and as the site representative for Quality Catch, WSVA and other applicable initiatives.Document nonconformances using a high standard of technical writing and a detailed understanding of containment, disposition, risk assessment and investigation.Identify and drive corrective actions, when required, to prevent, eliminate, facilitate or mitigate the recurrence of nonconformances.Review complaint signals and complete investigations for individual events and unfavorable trends.Solve problems and determine appropriate actions by analyzing possible solutions and their impact on the business or technology.Organize and present data and information to influence decision-making.Maintain and enhance cross-functional and site team relationships.Actively contribute to continuous improvement and innovation from a preventive quality perspective.Collaborate effectively as a team member to achieve and demonstrate best practices aligned with department and site objectives.Apply strong organizational and time management skills to complete work in a timely manner.Prioritize a diverse workload to ensure the timely completion of critical tasks.Plan and execute daily activities and long-term projects to meet established timelines.Explain technical topics clearly to diverse stakeholders through effective communication.Make informed decisions related to product quality, including the disposition of nonconforming product.Apply appropriate statistical tools for sampling, capability analysis, trend analysis and control charts, and effectively interpret and present conclusions.Participate directly in new product and technology transfers, ensuring compliance with applicable internal and regulatory requirements.Support change control for work instructions, protocols, reports and technical documents as a change owner or quality approver.Apply knowledge of QSR and ISO/MDD standards, promote awareness of industry best practices and make appropriate daily quality decisions, escalating critical quality decisions to the Quality Manager or Quality Director as appropriate.Apply knowledge of risk management principles to support effective, risk-based decision-making.Education & Experience:Level 8 Hons Bachelor Degree (or higher) in Engineering or related fieldMinimum of 5 years' relevant experience, ideally within the medical device industry or another highly regulated environment.Preferred qualifications:Experience applying quality assurance principles within a medical device or other highly regulated environment.Experience with nonconformance investigations, CAPA, complaint investigations, risk management and change control.Knowledge of applicable 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.As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careersAt Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email [e-mail]..