Boston Scientific Quality Eng - P3 

Ireland 

432149984

Key Responsibilities:

• Quality support for the Product Development of Spy DS 3.0 and its transfer into manufacturing in BSC Clonmel.
• Develop an in-dept knowledge of the quality process behind the product development activities for new products.
• Develop and/or review Design Validation activities, Process Qualifications, Test Method Validations, ESQ’s, Process Capability studies, Design of Experiment (DOE in support of new product introduction into manufacturing.
• Lead/own any change -related activities in support of transfer, including the establishment of any site-specific systems/controls required for the manufacture of Scopes products at the Clonmel site.
• Lead the establishment of all Process Monitoring and activities, Acceptance Activities and inspections, and product controls for the Spy 3.0 assembly lines in Clonmel.
• Support process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance product design and new product development.
• Coordinates and conducts technical investigation and documentation of non-conforming events and trends using technical investigation plans, eCAPA and BSC Engineering Essentials.
• Ensure Regulatory compliance in projects of responsibility by utilising quality tools and processes.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Be part of a strong team culture around high expectations & high performance.
• Provide clear communication to stakeholders at key technical updates.

A developing professional with a working knowledge and application of the BSC Quality System specifically around Production and Process Controls, Process Acceptance Activities, Non-conforming product controls and CAPA.

Problem Solving:

Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on manufacturing.

Planning and Organisation:

Plans, organizes, and prioritizes own daily work routine to meet established schedule.

Provides guidance to less experienced staff.

Qualification Requirements:

BSc in Engineering/Quality/Science with a minimum 5 years’ experience in a Medical Device environment or related industry.

Demonstrate strong leadership skills, communication skills and promote quality at source.

A minimum of 1 year tenure in BSC.