QA Specialist II, APAC

Boston Scientific Gruppe; Penang; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading medical device company seeks a QA Specialist II to manage quality assurance activities across APAC. The ideal candidate will have a Bachelor's degree, 3-5 years of experience in quality or regulatory positions, and proficiency in English, Bahasa Malaysia, and Chinese. Responsibilities include executing quality processes and supporting cross-country initiatives. Competitive compensation and career advancement opportunities are offered.

Qualifications

• 3-5 years of experience in Quality or Regulatory functions, preferably in medical devices.
• Familiarity with ISO 13485, GMP, or similar regulations.
• Proficiency in English, Bahasa Malaysia, and Chinese required.

Responsibilities

• Execute centralized quality processes including document review and data verification.
• Maintain trackers and dashboards for accuracy of information.
• Support QA processes across countries and contribute to improvement initiatives.

Skills

Quality Assurance

Regulatory Compliance

Organizational Skills

Communication Skills

Problem-solving

Education

Bachelor's degree in engineering or equivalent

Tools

Microsoft Excel

Microsoft Word

Microsoft Visio

Microsoft PowerPoint

Job description

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

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

Requisition ID:613719

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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