QA Specialist I, APAC

Boston Scientific Gruppe; Penang; On-site; MYR 50,000 - 70,000; Full time

Job summary

A leading medical device company in Malaysia is seeking a QA Specialist I to handle various Quality Assurance activities for APAC countries. The successful candidate will execute centralized quality processes, ensure regulatory compliance, and maintain quality documentation. Candidates should have a Bachelor’s degree and 1-2 years of related experience. Proficiency in English, Bahasa Malaysia, and Chinese is required, along with strong organizational and communication skills.

Qualifications

• 1-2 years of experience in Quality, Regulatory, or related function, preferably in medical devices.
• Basic understanding of quality systems, procedures, and documentation.

Responsibilities

• Execute day-to-day activities for centralized quality processes.
• Maintain trackers and dashboards for timely information.
• Act as point of contact on requests from affiliates.

Skills

Organizational skills

Communication skills

Proficiency in English

Proficiency in Bahasa Malaysia

Proficiency in Chinese

Problem-solving methodologies

Education

Bachelor's degree in engineering or equivalent

Tools

Microsoft Excel

Microsoft Word

Microsoft Visio

Microsoft PowerPoint

Job description

Purpose Statement

The QA Specialist I, 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
• Participate in improvement initiatives as assigned, contributing to project activities in support of standardization and efficiency goals
• Act as the point of contact on requests from affiliates, supporting and providing the required data or information
• May support SME and Manager in maintaining high level of control of the quality processes
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• 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
• 1-2 years of experience in Quality, Regulatory, or related function, preferably in medical devices or regulated industry
• Basic understanding of quality systems, procedures and documentation
• Good organizational and communication skills, ability to interact with regional stakeholders
• Proficiency in Microsoft Excel, Microsoft Word, Microsoft Visio and Microsoft PowerPoint
• Language requirements: Proficiency in English, Bahasa Malaysia and Chinese (written and spoken) is required to manage documentation and communication across APAC countries

Requisition ID:613718

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!

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