Senior Quality Engineer at Boston Scientific Corporation Malaysia

Cluain Meala, Munster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

16 Jan, 26

Salary

0.0

Posted On

18 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Regulatory Compliance, Problem Solving, Continuous Improvement, Project Management, Cross-Functional Collaboration, Data Analysis, Mentoring, Communication, Attention to Detail, Operational Efficiency, Product Development, Audit Coordination, Customer Complaint Resolution, Innovation, Teamwork

Industry

Medical Equipment Manufacturing

Description

Provide expert quality engineering support throughout the entire product development lifecycle, from concept through commercialization, ensuring that design inputs, outputs, and validations align with regulatory and internal quality requirements. Collaborate closely with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Supply Chain to integrate quality principles into product design and development processes. Lead and facilitate structured problem-solving activities to address product and process issues, non-conformances, and customer complaints. Drive continuous improvement initiatives and lead Value Improvement Projects (VIPs) aimed at enhancing product quality, reducing cost, and improving operational efficiency. Plan, coordinate, and execute internal audits and support external inspections by regulatory bodies, maintaining a state of audit readiness and ensuring compliance to Quality System requirements. Develop, monitor, and report on key quality metrics and performance indicators to identify trends, drive decision-making, and support strategic planning. Mentor and coach junior engineers and team members, fostering a culture of quality, innovation, and continuous learning across the organization. Manage multiple projects and priorities simultaneously, demonstrating strong organizational skills, attention to detail, and the ability to deliver results within tight timelines. Honours bachelor's degree (Level 8) in engineering, Science, or a related technical discipline. Minimum of 5 years' experience in a Quality Engineering role within the medical device or regulated manufacturing industry. Demonstrated experience in leading product development initiatives and cross-functional project teams. Exceptional analytical, communication, and organizational skills, with the ability to influence and engage stakeholders at all levels. Highly self-motivated and proactive, with a strong sense of ownership and accountability. Excellent communicator, capable of presenting complex data and insights in a clear and compelling manner. Strong problem-solving mindset, with the ability to think critically and act decisively under pressure. Meticulous attention to detail and a structured approach to planning and execution. Collaborative team player who thrives in a fast-paced, multidisciplinary environment. Passionate about quality, innovation, and delivering products that improve patient outcomes.

Responsibilities

Provide expert quality engineering support throughout the product development lifecycle and collaborate with cross-functional teams to integrate quality principles. Lead problem-solving activities and drive continuous improvement initiatives to enhance product quality and operational efficiency.