QA Specialist II, APAC at Boston Scientific Corporation Malaysia

Simpang Ampat, Penang, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

06 Mar, 26

Salary

0.0

Posted On

06 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Compliance, Document Review, Data Verification, Process Tracking, Data Analysis, ISO 13485, GMP, Project Management, Continuous Improvement, Lean, Six Sigma, Communication Skills, Organizational Skills, Microsoft Excel, Microsoft Word

Industry

Medical Equipment Manufacturing

Description

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 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

Responsibilities

The QA Specialist II will execute day-to-day activities for centralized quality processes, including document review and data verification. They will also support cross-country QA processes and contribute to improvement initiatives.