Senior Quality Executive

BD Mexico; Kuala Lumpur; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading healthcare company is seeking a Quality Systems leader in Kuala Lumpur. This role involves ensuring quality process compliance, supporting post-market activities, and driving continuous improvement initiatives. The ideal candidate will have strong experience in regulatory compliance and project management, and will serve as the subject matter expert for ERP systems. This position requires excellent collaboration skills and the ability to manage various quality projects effectively.

Qualifications

• Experience in ISO 13485 and regulatory compliance is essential.
• Proven track record in quality management and process improvement.
• Strong analytical skills and experience in data analysis.

Responsibilities

• Support Management Representative for QMS processes.
• Lead quality compliance and post-market activities.
• Manage projects from initiation to closure.

Skills

Quality Systems Management

Regulatory Compliance

Data Analysis

Continuous Improvement

Leadership

Project Management

Team Collaboration

Education

Degree in Quality Management, Engineering or related field

Tools

ERP systems (SAP, JDE)

Quality tools and statistical methods

Job description

Overview

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 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

Responsibilities

• Support the Management Representative for ISO 13485 and GDPMDS by ensuring QMS processes are established, implemented, and reported accurately to senior management.
• Assist with post‑market 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 cross‑functionally 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 ad‑hoc quality reports and identify opportunities for simplification and standardization.
• Support customer‑facing 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 country‑specific labeling requirements.
• Provide support for Indonesia DC quality operations, SAP DTS‑Quality and ITR‑DMS, and CUP access management for GA countries.
• Perform tasks and projects assigned by Management.

Location

Primary Work Location: MYS Kuala Lumpur - Jalan Kerinchi

Equal Opportunity

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.