Job Description:
Boston Scientific is seeking a Dynamic Quality Engineer to support all aspects of Litho Vue production line in our Clonmel facility.
Purpose:
This role offers a significant opportunity to gain in-depth knowledge of the BSC Quality System, specifically Production and Process Controls and CAPA.
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.
* Captures and conducts technical investigation and documentation of non-conforming events and trends and develop technical investigation plans using e CAPA and BSC Engineering Essentials.
* Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality engineering issues.
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.
About Boston Scientific:
Boston Scientific is a global medical technology leader committed to transforming lives through innovative medical solutions. Our mission is to advance science for life, improving patient lives, creating value for our customers, and supporting our employees and the communities in which we operate.
We offer a collaborative culture driven by a passion for innovation, a comprehensive benefits package, life-work integration, and career growth opportunities.