Boston Scientific Quality Engineer 

Ireland 

972712936

Key Responsibilities:

• Develop an in-depth knowledge of the manufacturing engineering process for the scope’s products including all aspects of engineering production and process controls in-place on these manufacturing lines.

• Develop and/or review Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), and production control plans in support of product transfer to ensure meets Quality engineering standards

• Pro-actively implements Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements.

• Lead the translation and establishment of all Process Monitoring and activities, Acceptance Activities and inspections, and non-conforming material and product controls for the Scopes assembly lines in Clonmel.

• Post-transfer identifies and controls Quality manufacturing engineer -related process defects (scrap, nonconforming material, customer complaints) by participating/leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.

• Leads Quality engineer process improvement efforts by identifying methods to capture Quality metric data and by performing appropriate Quality analysis methods to enhance sustaining product design and new product development.

• Coordinates and conducts technical investigation and documentation of non-conforming events and trends and develop technical investigation plans using eCAPA and BSC Engineering Essentials.

• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality engineering issues.

• Be part of a strong team culture around high expectations & high performance.

• Provide clear communication to stakeholders at key technical updates.

• Support and prepare for site level internal and external audits.

• Support the transfer of the production lines for BSC Urology Scopes products from the BSC Spencer facility to BSC Clonmel.

Qualification / Requirements:

• L8 Hons Bachelor’s Degree in either Engineering, Quality or Science

• Experience in a Medical Device environment or related industry desired but not necessary.

• Demonstrate strong leadership skills, communication skills, and promote Quality at source.