Quality Assurance Manager

Why Ansell

At Ansell, we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance people's quality of life. As a global leader in protection solutions, we design and develop a wide range of products including gloves, clothing, and other protective gear to keep workers safe and productive across industrial, medical, and consumer applications.

Discover more about our company, our people, and our values by visiting us at Ansell.

Ansell is looking for a QA Manager to join our team in Malaysia!

In this position you will play a vital role in lead end‑to‑end Quality Assurance operations at the manufacturing site, driving compliance, product quality, and on‑time delivery through strong cross‑functional collaboration. Develop and maintain an effective QMS aligned with GMP and global regulatory standards. Champion a company‑wide quality mindset through leadership, engagement, and continuous improvement initiatives. Support business objectives by managing QA budgets and ensuring alignment between financial plans, customer needs, and regulatory requirements.

What benefits and opportunities does Ansell offer

• Competitive compensation, including a performance-based annual incentives
• An inclusive and collaborative environment that values diversity and fosters an international culture
• Ansell University programs to develop professional and interpersonal skills
• Opportunities to advance and grow within the company

What your role will be

1) Quality Management Systems

• Plan, coordinate and manage the Plant Quality Management System (QMS) ensuring that all requirements of relevant and applicable standards to the business are met, to maintain the required certifications.
• Monitor Management Systems performance and report effectiveness to relevant stakeholders and make the necessary recommendations for improvement.
• Ensure promotion of awareness of QMS and others, as applicable, Regulatory and customers requirements throughout the Ansell plant.

2) Audits

• Manage the internal audit system and audit program, for applicable standards and for all internal and external audits, including third party and customer audits and supplier audits and assure timely completion of audits, and submit findings and corrective action requests to management.
• Be a part of audit teams, as necessary, and participate inter-plant audits as requested.

3) CAPA

• Develop and implement effective and timely corrective and preventive actions to address quality control issues, and others, and prevent recurrences as required.

4) Regulatory Affairs

• Manage and maintain the regulatory and legislative documentation related to the products and Quality System, ensuring that quality system follows regulatory and legislative requirements.

5) Control of Non-conforming Products

• Ensure effective control of non-conforming product and authorize its disposition in accordance with requirements.

6) Documentation

• Manage the Document Management System (DMS) ensuring that all documents are created, stored, accessed, and distributed according to defined standards and procedures.
• Manage storage, retention and access of all regulatory and legal documents and records in accordance with applicable requirements.

7) Customer Complaint Management

• Provide the highest level of investigation and resolution of complaints and ensure the timeliness and effectiveness of their closure, and prevent recurrence and field recalls through an effective process of corrective and preventive action.

8) Change Control Management

• Ensure that the Global SOP for Change Management is followed to ensure process effectiveness.
• Advise on changes and their implementation and provides training, tools and techniques to enable others to achieve quality

9)Validations

• Provide support for NPDs validation and for any other change such as process, raw material and equipment change for the Plant.
• Support software validation carried out in the company to ensure compliance with QMS & GMPs.

10) Technical Support to Manufacturing

• Provide technical and quality advice related to trouble shooting of new/existing manufacturing/quality problem, to new raw material evaluation & implementation and procedural changes and to process and product improvement.

11) Incoming, In-process & Final Release Product Inspection and Certification.

• Manage and maintain effectiveness of Incoming, In-process & Final Release Inspection activities.
• Authorize finished product releases and approve on product conformance certificates.

12) Supplier / Vendor Evaluation

• Work with Plant Procurement and/or Global Source to establish external supplier quality requirements and support the introduction and qualification of new suppliers/vendors and/or materials to ensure strict compliance of new suppliers and new materials with Ansell requirements.
• Manage and monitor supplier performance, establish supplier development program and provide training to key suppliers when necessary. Initiate SCAR (Supplier Corrective Action Request) on critical supplier issues and ensure timely and effective closure.

13) Laboratory Testing

• Manage the Lab resources to provide timely and reliable test results, as applicable.
• Ensure continued accreditation of QC/QA Lab against ISO/IEC 17025, when applicable, and manage it according to relevant requirements.

14) Product Compliance

• Develop and implement quality control strategies, policies, and procedures to ensure consistent delivery of high-quality products throughout all manufacturing processes.

15) NPD

• Closely working with Global R&D, marketing, regulatory and other Ansell Stakeholders to define, develop and deploy product quality assurance strategy, addressing all phases of product development ensuring new product quality from design to manufacturing and the fulfilment of QA & regulatory requirements.

16) Team Management

• Recruit, promote and develop people, in agreement with Global QA, and take disciplinary actions as the situation demands.
• Lead and manage QA Team effectively, providing guidance, coaching, training and support as needed.

17) Others

CMR & SHE - Ensure department complies with Safety, Health & Environment (SHE) requirements. Meet corporate compliance and carry out assigned responsibilities related with EMS and SHE requirements.

ERP - Plant Leader of the QMS Module. Ensure the QA Business Scenarios implementation in the ERP without Gaps. Work with Global ERP implementation & Local ERP consultants for the effective implementation of the QA Module.

APS - Support Ansell Production System to enhance overall efficiency and quality and manage/coordinate QA Pillar.

What will you bring to Ansell

• Demonstrated experience in hands-on experience with Quality System Standards
• Good knowledge in ISO 9001, ISO 13485 (for medial only), 21 CFR, REACH, GMP and QMS requirement
• Auditor qualification
• Process control, effective manufacturing/QA control
• Good analytical skills and attention to details.
• Good drive for results and commercial access.
• This role required to travel to other Ansell location as required by the company on business and job-related matters.

Join us to lead the world to a safer future, apply today!

Equal Opportunity Employer

Ansell is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed or ancestry, sex, physical or mental disability, genetic information, parental status, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Our Commitment to Belonging and Inclusion

Ansell's vision is about creating safe spaces where all perspectives are valued alongside individual contributions. When we say that everyone deserves to belong, feel included and empowered at work., it's not just words. We want applicants to know that we endeavor to create an inclusive environment that will consider all, regardless of gender, background, disability, or experience alone! It's what drives Ansell as an organization towards a workforce that reflects the communities in which we operate, it's what drives us to serve our customers and stakeholders with pride, and it's what differentiates Ansell.

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