Quality Engineer - P3

Quality Engineer - P3

Work mode: Onsite

Onsite Location(s): Clonmel, IE

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.

Advancing possibilities for a brighter tomorrow

Job Description

Develops, establishes and maintains quality methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Ensures implementation of assurances, process controls, and CAPA systems designed to meet and exceed internal and external requirements. Drives excellence across product development, quality assurance and operational efficiency. Supporting initiatives that ensure the design, development and manufacture of medical devices meet the highest standards of quality, safety and regulatory compliance. The role demands a strategic thinker with strong analytical capabilities, exceptional organisational skills and a passion for solving complex problems in a dynamic, cross-functional environment.

Key Responsibilities

• Develop an in-depth knowledge of the manufacturing process for active implantable products including all aspects of production and process controls.
• Develop and/or review Process Qualifications, Test Method Validations, Gage R&R's, Process Capability studies and production control plans.
• Lead/own change-related activities in support of product development, quality assurance and operational efficiency.
• 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.
• Identifies and controls manufacturing-related process defects (scrap, nonconforming material, customer complaints) by participating/leading efforts/teams focused on identifying the primary root causes, implementing corrective and preventative actions and quality data analysis.
• 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.
• Ensure Regulatory compliance in projects of responsibility by utilising quality tools and processes.
• Leads investigations on internal & external customer complaints.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work with manufacturing, supplier quality, and design teams to support new product introductions and continuous improvement initiatives.
• Be part of a strong team culture around high expectations & high performance.
• Provide clear communication to stakeholders at 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

Will be required to provide guidance to less experienced staff.

Qualification Requirements

Higher Level Honours Degree/Level 8 qualification in Engineering/Quality/Science with a minimum 5 years' experience in a Medical Device environment or related industry. Demonstrate strong communication skills and promote quality at source.

So, choosing a career with Boston Scientific 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!