Associate Specialist, QA

Ansell Global Trading Center (Malaysia) Sdn Bhd; Kulim; On-site; MYR 47,000 - 71,000; Full time

Benefits offered by this job

Competitive remuneration

Annual performance bonuses

Inclusive environment

International workplace culture

Job summary

Ansell Global Trading Center (Malaysia) Sdn Bhd in Kulim, Kedah is seeking an Assoc Specialist, QA to maintain the Plant Quality Management System (QMS) in line with ISO 9001, regulatory requirements and GMP standards. You will coordinate internal and external audits, drive CAPA closure, and support continuous quality improvement.

The role also involves training, tracking actions from Management Reviews, and reporting quality metrics to strengthen overall plant performance and supplier

Qualifications

• Bachelor’s degree in Science, Mathematics, Quality Management, Manufacturing or related field.
• Minimum 2–3 years of experience in Quality Assurance, Quality Systems, Document Control, Compliance, or related field.
• Knowledge of Quality Management Systems and ISO 9001 requirements.
• Knowledge of document control, CAPA, audit management, Management Review, and quality record requirements.
• Basic knowledge of root cause analysis, risk-based thinking, AI, and statistical analysis.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
• Strong analytical, reporting, planning, organizational, prioritization, and problem-solving skills.
• Effective written and verbal communication with attention to detail.
• Ability to work collaboratively, demonstrate accountability, and take ownership of assigned responsibilities.
• Willingness to travel from time to time based on organizational and job requirements.

Responsibilities

• Maintain, monitor, and continually improve the plant QMS in accordance with ISO 9001 and GMP.
• Monitor QMS performance indicators, quality objectives, and improvement initiatives; analyze trends.
• Coordinate control of quality documents and records, including archiving and removal of obsolete docs.
• Plan and coordinate internal quality system and process audits; support external audits.
• Maintain audit, nonconformance, and CAPA tracking; ensure timely closure and verification.
• Support root cause investigations and corrective/preventive actions.
• Coordinate QMS training and maintain training records and compliance.
• Compile quality metrics for Management Review Meetings and report progress.
• Work with supply team to manage supplier qualification and certifications.
• Identify initiatives to strengthen QMS effectiveness and escalate major risks.

Skills

Quality Assurance

Quality Systems

Document Control

CAPA

Audit Management

Management Review

Quality Records

Root Cause Analysis

Risk-Based Thinking

Statistical Analysis

MS Office

Excel

Communication Skills

Attention to Detail

Travel Willingness

Education

Bachelor’s degree in Science/Quality Mgmt

Job description

Ansell Global Trading Center (Malaysia) Sdn Bhd 4.0 View all jobs

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well-being. As the need for better protection continues to grow, Ansell remains committed to researching, developing, and investing in innovative products and technologies that are marketed under trusted global brands. Operating across two business segments—Industrial and Healthcare—Ansell employs approximately 14,000 people worldwide and continues to grow as a market leader.

For more information about our Company, our People, and our Values, please visit: https://www.ansell.com

Ansell is looking for an Assoc Specialist, QA to be based in Kulim, Kedah.

The Associate Specialist, QA is responsible for maintaining and ensuring the effectiveness of the Plant Quality Management System (QMS) and related procedures in compliance with applicable standards, regulatory requirements, customer expectations and Good Manufacturing Practices requirements. The role coordinates internal quality system audits and process audits to assess compliance and identify opportunities for continual improvement.

The incumbent provides training and awareness programs on quality-related requirements, supports the preparation of Management Review Meeting (MRM) inputs, tracks the closure of action items arising from management reviews, monitors Quality Objectives performance, and evaluates the effectiveness of implemented improvement initiatives.

The position is also responsible for coordinating and supporting external system certification audits, product audits, and customer audits, ensuring audit findings and corrective and preventive actions (CAPA) are effectively implemented, timely closed, and verified for effectiveness. Through effective monitoring, coordination, and reporting of QMS activities, the role contributes to sustaining compliance, driving continuous improvement, and enhancing overall quality performance across the plant.

What Can You Expect from Ansell?

• Work for a global leader in the health and safety protection solutions industry.
• A secure workplace with competitive remuneration and annual performance bonuses.
• An inclusive, collaborative, and supportive work environment.
• Exposure to a diverse and international workplace culture.

What Will Your Role Be?

• Maintain, monitor, and continuously improve the plant Quality Management System (QMS) in accordance with ISO 9001, internal procedures, regulatory requirements, customer expectations, and applicable Good Manufacturing Practices.
• Monitor QMS performance indicators, quality objectives, and improvement initiatives; analyze trends and prepare periodic quality reports.
• Coordinate the review, revision, approval, issuance, control, retention, and archival of quality documents and records, including removing obsolete documents from points of use.
• Plan and coordinate internal quality system and process audits, and support external certification, product, customer, and supplier-related audits.
• Maintain audit, nonconformance, and CAPA tracking systems; follow up with responsible departments to ensure timely closure and verification of effectiveness.
• Support root cause investigations, risk-based assessments, and the implementation of corrective, preventive, and quality improvement actions.
• Coordinate QMS-related training and awareness activities, maintain training matrices and records, and monitor training compliance and effectiveness.
• Compile quality metrics and inputs for Management Review Meetings, track resulting action items, and report progress through closure.
• Work with the supply team to maintain supplier qualification records and certifications, monitor certification expiry, and support supplier evaluation and requalification.
• Identify and support initiatives that strengthen QMS effectiveness, compliance, and overall plant quality performance.
• Escalate significant quality system risks or compliance concerns to management in a timely manner.
• Support urgent QMS activities, attend relevant quality and compliance training, and serve as an alternate champion for QMS-related projects when appointed.

What Will You Bring?

• Bachelor’s degree in Science, Mathematics, Quality Management, Manufacturing, or a related discipline.
• Minimum 2–3 years of experience in Quality Assurance, Quality Systems, Document Control, Compliance, or a related field, preferably in a manufacturing environment.
• Knowledge of Quality Management Systems and ISO 9001 requirements.
• Knowledge of document control, CAPA, audit management, Management Review, and quality record requirements.
• Basic knowledge of root cause analysis, risk-based thinking, artificial intelligence, and statistical analysis.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
• Strong analytical, reporting, planning, organizational, prioritization, and problem-solving skills.
• Effective written and verbal communication skills, with strong attention to detail.
• Ability to work collaboratively, demonstrate accountability, and take ownership of assigned responsibilities.
• Willingness to travel from time to time based on organizational and job requirements.

MY Kedah Kulim No 3

No 3Jalan Perusahaan 2 Kulim Industrial Estate

Kulim09000