Quality Engineer - Complaints - P2 at Boston Scientific Corporation Malaysia

Galway, Connacht, Ireland -

Full Time

Start Date

Immediate

Expiry Date

19 Jan, 26

Salary

0.0

Posted On

21 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Complaint Management, Data Analytics, Root Cause Analysis, Process Improvement, Project Management, Problem Solving, Technical Capabilities, Communication Skills, Organizational Skills, Product Design, Manufacturing, Clinical Use Environment, Angiographic Image Review, Laboratory Testing

Industry

Medical Equipment Manufacturing

Description

Ownership of the execution of complaint approvals within the BSC Global Complaints Management System which includes a comprehensive review of Complaint Investigations to ensure they meet regulatory and BSC requirements. Ownership of the execution of complaint investigations within the BSC Global Complaints Management System which includes execution of insightful laboratory testing on returned complaint devices, where required. Complaint event root cause analysis and determining investigation pathways and any actions to be taken. Using data analytics tools to monitor product performance and investigation process performance. Preparation and provision of complaint trend data and sharing of data and trend analysis at review forums. Drives continuous improvement initiatives to investigation methodology and associated processes and lead applicable projects of improvement. Make decisions and determine escalation pathways, as well as demonstrating ability to work on one's own initiative and with minimum supervision is required. Understands and complies with all the regulations governing the quality systems. Development and maintenance of collaboratively relationships within the Galway investigation team, and with other investigation and complaint management centre teams across the global Post Market Quality Assurance function. Development and maintenance of partnerships with Quality Operations, Design Assurance, Field Support and R&D for the execution of insightful investigations and to support product performance improvements. HETAC Level 8 qualification in a STEM subject with a min. of 2-3 years relevant work experience. Demonstration of problem solving, process improvement and/or project management skillsets and application. Demonstration of taking initiative to drive improvement and change. Knowledge on product design, manufacture, functionality and/or clinical use environment. Experience of product design or manufacturing would be an advantage. Good technical capabilities, communication skills and organisation skills. Ability to analyse data to gain insights and to share information effectively. Proven ability to work well with teams but also with minimum supervision. Experience of Angiographic image review experience would be an advantage. Hepatitis B Vaccinations course required to work with returned decontaminated product.

Responsibilities

The Quality Engineer will oversee the execution of complaint approvals and investigations within the BSC Global Complaints Management System, ensuring compliance with regulatory requirements. They will also drive continuous improvement initiatives and collaborate with various teams to enhance product performance.