Quality Engineer III

About Boston Scientific

Join Boston Scientific, a pioneer with over 40 years leading medical science innovation dedicated to improving patient outcomes through advanced healthcare solutions. We value diverse, high-performing teams committed to tackling significant health industry challenges and offer access to cutting-edge tools and training to elevate your professional growth.

Role Overview

We are seeking a Quality Engineer III on a fixed 12-month contract to provide critical Process and Quality Engineering support at our manufacturing facility in Clonmel, Ireland. Your role will be pivotal in ensuring the consistent delivery of top-quality products to customers while supporting product development teams in launching new, high-standard medical devices.

Key Responsibilities

• Identify and manage manufacturing process defects such as scrap, nonconforming materials, and customer complaints by leading root cause investigations and implementing corrective and preventive actions.
• Develop comprehensive product quality documentation including product specifications, quality plans, and risk assessments like FMEAs.
• Lead initiatives to improve processes by collecting quality metrics and performing detailed analyses to support both sustaining and new product designs.
• Contribute to the creation of improved Quality Tools and Training Materials by evaluating current resources and recommending enhancements.
• Assess compliance and effectiveness of systems, operations, and practices against regulatory standards and company policies; potentially serve as an auditor within the quality system.
• Utilize SAP systems to support daily quality activities, troubleshoot issues, and generate reports; SAP experience is highly desirable.
• Support Corrective and Preventive Action (CAPA) efforts by investigating quality issues linked to data collection and SAP, performing root cause analysis, implementing solutions, and monitoring their success.

Qualifications and Experience

• Level 8 Honours Bachelor's degree or higher in Engineering or a related discipline.
• Three to five years of experience in manufacturing or quality roles.
• Proficient in written and verbal communication.
• Proven capability to collaborate across multiple functions in a dynamic manufacturing environment to resolve issues effectively.
• Strong skills in Microsoft Office applications including Word, Excel, and PowerPoint.
• Prior background in Quality or Manufacturing sectors.
• Experience within the medical device industry.
• Solid understanding of FDA regulations, ISO 13485 standards, and quality requirements pertinent to medical device manufacturing and supplier management.
• Experience with problem solving and process improvement techniques.
• Knowledge in Process Validation, Risk Management, and CAPA processes.
• Familiarity with SAP is highly advantageous; alternatively, a strong aptitude for learning new business systems is valued.

Additional Information

Boston Scientific is devoted to fostering an inclusive and diverse workplace that drives innovation and reflects the communities we serve. We uphold equality and provide reasonable accommodations for applicants and employees with disabilities. Joining us means engaging in a purpose-driven career that profoundly impacts patients worldwide.