Quality Engineer III

Boston Scientific Gruppe; Ireland; On-site; EUR 60,000 - 85,000; Full time

Job summary

Boston Scientific is seeking a Quality Engineer III on a 12-month defined term basis to provide process and quality engineering support to manufacturing and product development teams. The role involves defect control, quality planning, risk analyses, and CAPA activities to ensure the highest quality products reach customers.

You will work in a dynamic manufacturing environment with cross-functional teams, leveraging SAP for day-to-day quality processes and reporting.

Qualifications

• 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.
• Strong command of MS Office – Word, Excel, PowerPoint.
• Previous experience in a Quality or Manufacturing background.
• Experience in the medical device industry.
• Working knowledge of FDA, ISO13485 quality requirements.

Responsibilities

• Identifies and controls manufacturing process defects with root cause analysis and corrective/preventive actions.
• Develops product quality plans, specifications, and quality systems with team members.
• Leads process improvement by capturing quality metric data and applying analysis methods.
• Assists in creation of Quality Tools and Training Materials.
• Assesses compliance of systems and practices with regulation and company docs.

Skills

Communication skills

MS Office

Education

Bachelor Degree in Engineering or related field

Tools

SAP

Job description

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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

We are seeking a Quality Engineer IIIon a defined term basis (12 months) to join our team.

Job Purpose:

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.

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!

At 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] .

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