Senior Quality Executive

Becton Dickinson Sdn. Bhd.; Kuala Lumpur; On-site; MYR 80,000 - 100,000; Full time

Job summary

A leading medical technology company is hiring a Senior Quality Executive in Kuala Lumpur to oversee quality systems across the Greater Asia region. This role involves ensuring compliance with ISO standards, driving continuous improvement initiatives, and managing quality-related processes. Candidates should have significant experience in quality systems and regulatory compliance, strong analytical skills, and project management expertise. The position offers the opportunity to lead and implement quality strategies that align with global standards.

Qualifications

• Experience in quality systems and ensuring compliance with ISO 13485.
• Strong analytical skills for data analysis and root cause analysis (RCA).
• Demonstrated experience supporting compliance for regulatory requirements.

Responsibilities

• Ensure QMS processes are established and implemented according to standards.
• Lead post-marketing quality compliance activities.
• Conduct audits to verify compliance with applicable standards.

Skills

Quality systems leadership

Regulatory compliance monitoring

Data analysis

Continuous Improvement (CI)/LEAN

Project management

Tools

SAP

JDE

Quality tools

Job description

Senior Quality Executive, Quality Assurance

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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.

The role responsibilities include supporting post‑market 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 distributor‑related quality processes in Greater Asia, including operations at the Singapore Regional Distribution Center (RDC) and L‑Bard 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

1. Support the Management Representative for ISO 13485 and GDPMDS by ensuring QMS processes are established, implemented, and reported accurately to senior management.
2. Assist with post‑market quality compliance, including complaint handling, adverse event reporting, field actions, escalation processes, and regulatory compliance monitoring where necessary.
3. Lead GA Inspire Quality (IQ) implementation activities in alignment with Global/Regional plans.
4. Partner with country Quality & Compliance leaders to address regulator or government agency inquiries.
5. Lead the regional QS/PMQ network to interpret regulatory changes, assess impact, and develop necessary internal procedures to maintain compliance.
6. Represent the region in Global Quality Networks and build a strong culture of Quality, Compliance, and Continuous Improvement.
7. Provide periodic management reports and scorecards to regional leadership and stakeholders.
8. Serve as BD Holdings Internal Auditor, conducting audits per schedule to verify compliance with applicable standards and procedures.
9. Perform data analysis using quality tools and statistical methods to support investigations, RCA, CAPA, improvement initiatives, and performance measurement.
10. Promote and share best practices to drive continuous improvement across the region.
11. Support process improvement and standardization projects, working cross‑functionally as needed.
12. Manage assigned projects from initiation to closure.
13. Prepare management presentations and ensure quality documentation control systems are effective, accessible, and aligned with requirements.
14. Communicate effectively across multiple functional areas and levels of the organization, navigating ambiguity and complex environments.
15. Prepare and publish regular or ad‑hoc quality reports and identify opportunities for simplification and standardization.
16. Support customer‑facing presentation material development using sound data analytics.
17. Ensure the Singapore Distribution Centre maintains a compliant, robust Quality System in line with regulatory expectations and Quality Agreements.
18. Partner with Supply Chain/Logistics on GA distribution strategy, including DC improvements, distributor management, process optimization, and transport lane compliance.
19. Provide quality oversight of repacking, relabeling, kitting, bundling, rework, and related 3PL activities.
20. Support SAP 6.0 Material Master Data Extension approvals for GA distribution centers.
21. Manage product hold activities and drive timely issue resolution.
22. Act as SME for ERP systems (SAP, JDE) and secondary assembly operations.
23. Represent the GA region in global and regional quality initiatives, including Distribution Quality.
24. Create, revise, review, and approve global SOPs and support their implementation at the distribution center.
25. Train Quality associates on ERP and secondary assembly processes; provide quality insights on country‑specific labeling requirements.
26. Provide support for Indonesia DC quality operations, SAP DTS‑Quality and ITR‑DMS, and CUP access management for GA countries.
27. Perform tasks and projects assigned by Management.

Required Skills

Primary Work Location
MYS Kuala Lumpur - Jalan Kerinchi

Additional Locations

Work Shift