Boston Scientific QA Specialist II APAC 

Malaysia, Penang 

541585320

Purpose Statement

The QA Specialist II, APAC will perform a variety of Quality Assurance (QA) activities for the APAC countries to ensure compliance to internal procedure in accordance with Boston Scientific (BSC) Quality Systems. This includes developing, establishing, executing and maintaining quality systems and practices which meets BSC, customer and regulatory requirements.

Key Responsibilities

• Member of the Center of Excellence (CoE) for centralized quality activities and processes
• Executes day-to-day activities for the centralized quality processes such as document review, data verification and process tracking
• Maintain trackers, dashboards and reports to ensure accuracy and timeliness of information
• Assure the development and execution of streamlined centralized quality processes
• Support cross-country QA processes by ensuring data and documentation are aligned
• Member in improvement initiatives assigned, contributing to project activities in support of standardization and efficiency goals
• Identify process gaps, propose improvements, and contribute to standardization activities
• Provide training, guidance and support to junior team members
• Act as the point of contact on requests from affiliates, supporting and providing the required data or information
• May support the SME and Manager in maintaining high level of control of the quality processes
• Manage more complex QA tasks, including exception handling and problem-solving
• Perform collection, analysis, and trending of quality indicator data in support of management review and/or goals and objectives

Key Qualifications

• At least a Bachelor’s degree in any engineering or equivalent field
• 3 -5 years of experience in Quality, Regulatory, or other related functions, preferably in medical devices or regulated industry
• Demonstrated ability to apply conceptual knowledge to solve routine and moderately complex problems
• Familiarity with ISO 13485, GMP, or similar regulatory requirements
• Strong organizational and communication skills, ability to interact with regional stakeholders
• Exposure to project-based work or continuous improvement activities (Lean, Six Sigma, Kaizen, etc) is an added advantage
• Proficiency in Microsoft Excel, Microsoft Word, Microsoft Visio and Microsoft Point
• Language requirements: Proficiency in English, Bahasa Malaysia and Chinese (written and spoken) is required to manage documentation and communication across APAC countries