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Quality System Specialist

🔥 11 minutes ago

🌐 Singapore, Japan – Remote

infoinfo

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Quality Specialist

Where this job comes from

Posted on BD's careers page, not through a job board

First seen by Remote Rocketship 11 minutes ago

Logo of BD

BD

10,000+ employees

Founded 1897

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $24M Grant on 2020-07

Healthcare • Manufacturing • Healthcare Insurance

BD (Becton, Dickinson and Company) is a global medical technology company dedicated to advancing the world of health. It focuses on developing innovative technologies, services, and solutions to improve safety and efficiency in healthcare. BD offers a wide range of products including medication management solutions, surgical solutions, cervical cancer screening, drug delivery systems, and laboratory services. The company is also involved in infection risk management and provides advanced clinical insights to enhance patient outcomes. With a commitment to global health sustainability and social investing, BD is a leader in healthcare technology and services worldwide.

📋 Description

• Support regional leaders in transition planning for Quality Regional teams across Asia-Pacific countries • Perform transition and site-readiness activities at multiple locations in Asia and the Pacific region • Support identification and implementation of quality requirements for establishing and expanding global quality presence in APAC • Implement Quality Management System processes in compliance with applicable regulatory requirements • Support QMS certification, including ISO 13485 and ISO 9001, as appropriate • Identify when Quality Agreements are required with third-party logistics providers, distributors, and other external partners • Identify mandatory Quality roles under country-specific regulations • Identify Post-Market Quality requirements and timing for each country • Coordinate dependencies and communication with Regulatory Affairs, Supply Chain, Commercial, and Operations teams • Perform other assigned duties and responsibilities

🎯 Requirements

• Support transition planning for Quality Regional teams in the Asia-Pacific region and country-readiness programs • Experience or knowledge of Quality Management System processes and applicable regulatory requirements • Knowledge of QMS certification requirements, including ISO 13485 and ISO 9001 • Ability to identify when Quality Agreements with 3PLs, distributors, and other external partners are required • Ability to identify country-specific regulatory requirements for mandatory Quality roles • Ability to identify Post-Market Quality requirements and timing by country • Ability to coordinate with Regulatory Affairs, Supply Chain, Commercial, and Operations teams • Ability to work across multiple locations in Asia and the Pacific region

🏖️ Benefits

• Face-to-face collaboration culture • Equal opportunity employment

Apply Now

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