Boston Scientific QA Specialist / Senior year contract 

Malaysia, Penang 

739600888

Purpose Statement

This role supports/execute/implement all activities as driven by the restructuring program Synapsis. The role is expected to understand all quality processes in scope of the program, optimization and building efficient centralized processes in accordance with Boston Scientific (BSC) Quality Systems. This includes developing, establishing, and maintaining quality systems and practices which meet BSC, customer and regulatory requirements. Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Provide quality engineering support within technical development concepts, new product development, operational, or system/services support.

Roles & Responsibilities

• Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, regional and Global quality goals and priorities
• Establishing procedures for operational execution of centralized quality activities ensuring quality conformity to BSC quality systems
• Execute day-to-day activities when the centralized quality processes are operationally ready to be used
• Act as the point of contact on requests from affiliates, supporting and providing the required data or information
• May support SME and Manager, 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
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Collaborate and liaises with the APAC Quality Systems team and relevant working groups to drive continuous improvement
• Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues
• Advise management on potential improvements or enhancement to quality systems and processes in the company
• Ensures awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of BSC

Qualifications

• At least 5 years of experience in a QA related environment. Candidates with experience in the Medical Device or Pharma industry will be preferred
• Proven experience in a multi-national company with a matrix reporting structure
• Understanding of quality management system with experiences in the supplier quality management and/or post market surveillance processes
• Knowledge on SAP and project management would be an added advantage
• Pro-active, energetic, self-assured professional with ability to develop good interpersonal relationships with other entities of BSC
• Good communication skills with the ability to positively influence key stakeholders without direct authority
• Proficiency in Microsoft Excel, Word, and PowerPoint
• Tenacity in following through on details