Job Description Summary
This role provides Quality Systems leadership across the Greater Asia region, ensuring alignment with global standards and effective implementation of compliant, efficient quality processes that support business priorities.
Responsibilities include supporting postmarket activities—such as adverse event reporting and field actions—across all BDX business units, and contributing to regional quality and regulatory strategies.
The role drives Continuous Improvement (CI)/LEAN initiatives through analytical insights, supports timely and accurate management reporting, and ensures defined quality metrics are measured and used to identify improvement opportunities.
It also oversees distribution and distributorrelated quality processes in Greater Asia, including operations at the Singapore Regional Distribution Center (RDC) and LBard Distribution Center.
The position ensures Regional Distribution Centers in Singapore comply with relevant standards (e.g., ISO 13485, GDPMDS) and supports regional distribution strategy execution.
It also serves as Subject Matter Expert (SME) for Secondary Assembly and ERP systems (JDE/SAP).
Job Description
- Support the Management Representative for ISO 13485 and GDPMDS by ensuring QMS processes are established, implemented, and reported accurately to senior management.
- Assist with postmarket quality compliance, including complaint handling, adverse event reporting, field actions, escalation processes, and
regulatory compliance monitoring where necessary.
- Lead GA Inspire Quality (IQ) implementation activities in alignment with Global/Regional plans.
- Partner with country Quality & Compliance leaders to address regulator or government agency inquiries.
- Lead the regional QS/PMQ network to interpret regulatory changes, assess impact, and develop necessary internal procedures to maintain compliance.
- Represent the region in Global Quality Networks and build a strong culture of Quality, Compliance, and Continuous Improvement.
- Provide periodic management reports and scorecards to regional leadership and stakeholders.
- Serve as BD Holdings Internal Auditor, conducting audits per schedule to verify compliance with applicable standards and procedures.
- Perform data analysis using quality tools and statistical methods to support investigations, RCA, CAPA, improvement initiatives, and performance measurement.
- Promote and share best practices to drive continuous improvement across the region.
- Support process improvement and standardization projects, working crossfunctionally as needed.
- Manage assigned projects from initiation to closure.
- Prepare management presentations and ensure quality documentation control systems are effective, accessible, and aligned with requirements.
- Communicate effectively across multiple functional areas and levels of the organization, navigating ambiguity and complex environments.
- Prepare and publish regular or adhoc quality reports and identify opportunities for simplification and standardization.
- Support customerfacing presentation material development using sound data analytics.
- Ensure the Singapore Distribution Centre maintains a compliant, robust Quality System in line with regulatory expectations and Quality Agreements.
- Partner with Supply Chain/Logistics on GA distribution strategy, including DC improvements, distributor management, process optimization, and transport lane compliance.
- Provide quality oversight of repacking, relabeling, kitting, bundling, rework, and related 3PL activities.
- Support SAP 6.0 Material Master Data Extension approvals for GA distribution centers.
- Manage product hold activities and drive timely issue resolution.
- Act as SME for ERP systems (SAP, JDE) and secondary assembly operations.
- Represent the GA region in global and regional quality initiatives, including Distribution Quality.
- Create, revise, review, and approve global SOPs and support their implementation at the distribution center.
- Train Quality associates on ERP and secondary assembly processes; provide quality insights on countryspecific labeling requirements.
- Provide support for Indonesia DC quality operations, SAP DTSQuality and ITRDMS, and CUP access management for GA countries.
- Perform tasks and projects assigned by Management
Required Skills
Optional Skills
Primary Work Location
MYS Kuala Lumpur - Jalan Kerinchi
Additional Locations
Work Shift
