Quality Engineer III

Boston Scientific; Clonmel; On-site; EUR 65,000 - 90,000; Full time

Job summary

Boston Scientific is seeking a Quality Engineer III on a 12-month defined-term basis to provide Process/Quality Engineering support to manufacturing and product development, ensuring delivery of high-quality products. The role involves creating quality plans, performing risk analyses, and driving CAPA actions across cross-functional teams.

The ideal candidate has an engineering degree, 3–5 years in manufacturing or quality, strong communication skills, and knowledge of FDA/ISO13485 quality

Qualifications

• Level 8 Honours Bachelor’s in Engineering or related field.
• 3-5 years’ experience in Manufacturing or Quality.
• Excellent written and verbal communication skills.
• Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment.
• Strong command of MS Office – Word, Excel, PowerPoint.
• Previous experience in a Quality, or Manufacturing background.
• Experience in the medical device industry.
• Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements.
• Experience in problem solving and process improvement methodologies.
• CAPA, Risk Management, and Process Validation experience.
• Experience using SAP is highly desirable.

Responsibilities

• Identifies and controls manufacturing process defects by participating in teams focused on root causes and corrective actions.
• Develops product quality plans, specifications, and quality plans with the team, and may create risk analyses and FMEAs.
• Leads process improvement by capturing quality metric data and performing analyses to enhance product design and development.
• Assists in creation of Quality Tools & Training Materials and identifies better tools/materials.
• Evaluates adequacy and compliance of systems, operations, and practices against regulation and company documentation; may audit quality system areas.
• Supports CAPA activities by investigating DC and SAP quality issues, performing root cause analysis and implementing actions.

Skills

Cross-functional

MS Office

Communication

Problem Solving

Quality Systems

Education

Level 8 Honours Engineering

Tools

SAP

Quality Tools

Job description

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At 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 tomorrow

Job Purpose:

We are seeking a Quality Engineer III on a defined term basis (12 months) to join our team. Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.

Key Responsibilities:

• Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.
• Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.
• Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
• Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
• Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.
• Experience using SAP is highly desirable, with the ability to use SAP to support day-to-day activities, troubleshoot system issues and generate reports to support quality processes.
• Supports CAPA activities by investigating DC and SAP related quality issues, performing root cause analysis, implementing corrective and preventive actions, and monitoring their effectiveness.

Education & Experience:

• Level 8 Hons Bachelor Degree (or higher) in Engineering or related field
• 3-5 years’ experience in Manufacturing or Quality
• Excellent written and verbal communication skills
• Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
• Strong command of MS Office – Word, Excel, PowerPoint.
• Previous experience in a Quality, or Manufacturing background.
• Experience in the medical device industry.
• Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.
• Experience in problem solving and process improvement methodologies.
• Process Validation, Risk Management, CAPA experience.
• Experience using SAP is highly desirable but not essential. Experience using similar systems or a strong aptitude for learning and working with new business systems will also be considered.

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.

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].