Quality Engineer III, APAC

Purpose Statement

The role of Quality Engineer III, APAC primarily supports the Capital Equipment Repair Center and has secondary support to the Regional Quality Systems team, in developing, establishing, and maintaining quality systems and practices which meet Boston Scientific's customer and regulatory requirements. Reporting to the Senior Quality Manager, APAC, this role provide quality engineering support within technical development concepts, new product development, operational, or system/services support.

Responsibilities

• Serves as a Quality representative to drive and lead quality awareness improvement, visibility, and communication on quality initiatives to support assigned departmental, functional, regional and Global quality goals and priorities.
• Acts as team member for Capital Equipment matters and Installation and Servicing processes, working alongside regional subject matter expect, Quality Systems and the country affiliate teams, ensuring compliance with Boston Scientific Corporation policies / procedures and local regulatory requirements across the region
• Supports SME and Management, Quality Systems in maintaining a high level of control of the process documentation and associated training across the region.
• Leads system improvement teams selecting appropriate techniques for problem solving and process improvements.
• Acts as quality contact person for Penang Repair Center supporting the daily quality activities of the service repair work.
• Takes a role in the management and preparation of the regional Management Review meeting data.
• Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
• Read and interpret technical drawings, procedures, and protocols
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and objectives.

Requirements

• Bachelor Degree in Engineering/ other science courses.
• Mininum of 6 years work experience in medical regulated industry –ISO 13485.
• Preferably with experience in Quality or Engineering with working experience in equipment manufacturing and equipment repair/ servicing.
• Having experience handling equipment/ tools in IM&T and equipment control is with added advantage.
• Strong problem-solver with the ability to navigate ambiguity and make sound decisions
• Able to work independently while managing multiple priorities
• Demonstrated pro-activeness working with team when managing projects is required

Requisition ID: 626956

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!