Boston Scientific Quality Engineer - P3 

Ireland 

526381404

Advancing possibilities for a brighter tomorrow

Key Responsibilities

• Subject Matter Expert for quality related queries in the SpyScope Manufacturing Operations area.
• Interacts cross functionally and with Internal and External Customers. Serves as a Clonmel point of contact for the BSC sites in Marlborough and Spencer for quality process related discussions / issues.
• Lead the resolution of Quality Related issues for the area by leading / 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 corrections / corrective actions & documenting release criteria.
• Leads projects & process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance and sustain Quality Metric performance in the area (including Best 4 strategic projects, Quality Catch Ownership, Project Prioritisation, WSVA, IQS, VIP)
• Provides Quality Engineering support to ongoing Engineering & Operations initiatives including process alignment & improvements, MES. Leads the implementation of improvement projects from a quality perspective.
• Manufacturing Quality representative for Design Change and Implantable Build Readiness activities
• Competent knowledge of Process Monitoring approach
• Provides Internal & External Audit support for Engineering & Operations. Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Responsible for external audit preparation activities for the area.
• 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.
• Coaches junior members of the team through a wide range of tasks from line support to project support.
• Knowledge of product labelling systems at Clonmel site

Educational Requirements

• Bachelors’ honors degree within a relevant field.
• 6+ years of experience working within a highly regulated environment.
• Medical Devices experience is desirable.
• Mentorship of junior team members.
• Must have a strong vision and an ability to influence the organization in the direction of Quality & Compliance.
• The successful candidate must be a self-starter with the ability to work on own initiative, while possessing strong team player characteristics.
• Strong communication skills required.

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