Sr Quality Engineer

Additional Locations:  N/A

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.

Job description:

Dynamic Quality Engineering role supporting all aspects of product transfer including the set-up of production lines in our Clonmel facility. Significant opportunity to gain in-dept knowledge of the BSC Quality System specifically Production and Process Controls and CAPA.  Will be responsible for Production lines post transfer, helping to ensure delivery of highest quality product to the customer.

Key Responsibilities:

• Support the transfer of the BSC Urology products from the BSC Spencer facility to BSC Clonmel.
• Develop an in-dept knowledge of the manufacturing process for the Urology scope products including all aspects of 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.
• 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 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.
• Lead a back room and provide front room support for External audits and to ensure that the Production unit are audit ready at all times.
• Post-transfer identifies and controls manufacturing-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 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.
• Coordinates and conducts technical investigation and documentation of non-conforming events and trends, and develop technical investigation plans using eCAPA and BSC Engineering Essentials.
• Leads investigations on customer internal & external complaints.
• 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

Knowledge:

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

Problem Solving:

Has experience in problem solving and process improvement methodologies (Engineering Essentials).

Planning and Organisation:

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

Business Relationships and Project Management:

Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. Will lead a project team. Will need to influence at peer level and at management level and above.

Mentoring:

Supervision will be involved. Will be required to provide guidance to less experienced staff.

Qualification Requirements:

• BSc degree in Engineering/Quality/Science or related discipline.
• 5+ years’ experience in a Medical Device environment or related industry.
• Demonstrate strong leadership skills, communication skills and promote quality at source.

#IJ

Requisition ID: 573675

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 (NYSE: BSX) 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!