Assoc Specialist, QA

Why Ansell

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 Ayer Keroh, Melaka.

This position is responsible to develop, administer and maintain quality assurance procedures and activities required to ensure that the company's processes and products comply to the medical device quality standards. Analyzing, identifying and implementing manufacturing and process improvements which will improve capability and performance that leads to products and services are of the highest quality. Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process inspection/testing and final product acceptance activities. Define quality control standards and test; specify test equipment and procedures. Active participation in all stages of design development, manufacturing and testing, ensuring compliance to quality assurance requirements.

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

• Ensure compliance with Quality Management System (QMS) requirements and applicable regulatory standards including FDA QSR (21 CFR Part 820), ISO 9001, EN ISO 13485, EU MDR, JPMDA, GDPMD, Korea MFDS, Indonesia Halal Management System, and other relevant regulations.
• Manage and maintain QMS documentation, including quality manuals, quality system specifications, SOPs, and other controlled documents to ensure accuracy and effectiveness.
• Support and coordinate internal and external audits, ensuring audit activities, customer requirements, and regulatory expectations are effectively addressed.
• Maintain product technical files and support regulatory documentation requirements, working closely with relevant stakeholders to ensure documentation completeness and compliance.
• Contribute to product and process quality activities, including verification and validation, Quality Function Deployment (QFD), Process Risk Analysis (PRA), and Control Plan implementation.
• Review quality and design-related documentation, ensuring compliance with established requirements, supplier quality expectations, and company quality standards.
• Provide training and guidance on quality systems and best practices, including Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
• Support the management of non-conformances, customer complaints, and quality investigations, including participation in MRB activities, root cause investigation, and resolution of recurring quality issues.
• Monitor QMS effectiveness and product quality performance, analyzing quality trends and supporting continuous improvement initiatives.

What Will You Bring

• Bachelor's Degree in Science, Biomedical, Engineering, Chemistry, Quality Management Systems, Materials, Polymers, or other related disciplines
• Minimum 2 years of experience in Quality Assurance, Quality Systems, or Quality Management Systems (QMS) within Medical Device or related industry
• Hands-on experience supporting Quality Systems, documentation control, audits, and compliance activities.
• Experience participating in internal and external audits (e.g., FDA, Notified Body, Customer, or Supplier audits)
• Medical Device Quality System Knowledge including ISO13485, ISO 9001, 21 CFR Part 820 (QSR) and Medical Device Regulation (MDR)
• Exposure to product registration or legally authorized representative activities will be an added advantage
• A Certified Quality Engineer or Certified Quality Auditor will be an added advantage
• Strong written and verbal communication skills.
• Ability to collaborate effectively with cross-functional teams and stakeholders.
• Strong attention to detail and documentation accuracy.