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.
Responsible for supporting the effective implementation, maintenance, and continual improvement of the Quality Management System (QMS) in compliance with applicable international standards and regulatory requirements. The role involves conducting Internal Quality Audits and process assessments against the latest versions of ISO 9001, ISO 13485, FDA QSR, Brazil GMP, JPAL, and Medical Device Regulations (MDR) to ensure organizational processes are compliant, effective, and consistently followed.
Ensures that quality requirements are effectively implemented across all functions, identifies gaps and improvement opportunities, supports corrective and preventive action implementation, and contributes to sustaining regulatory compliance and continual improvement of the QMS.
What benefits and opportunities does Ansell offer?
- Competitive compensation plan, including a performance based annual incentive.
- A culture of belonging and inclusion, collaboration thrives, and everyone feels seen, heard, and empowered across our global community.
- Ansell University, LinkedIn Learning and Mentorship programs to develop professional and interpersonal skills.
- Opportunities to advance and grow within the company through LinkedIn Learning and Mentorships.
What your role will be?
· Carry out process assessments effectively against the requirements of the established Quality Management System (QMS) and applicable regulatory standards.
· Identify, document, and report process assessment findings, including nonconformances and quality improvement requests, and formally communicate these findings via email to relevant stakeholders to initiate appropriate corrective and preventive actions (CAPA).
· Follow up on the implementation of corrective, preventive, and improvement actions and monitor the effectiveness of such actions to ensure sustained compliance and continual improvement.
· Utilize email and mobile communication tools effectively to ensure timely, clear, and accurate dissemination of quality-related findings and information.
· Plan, coordinate, and conduct internal quality audits in accordance with the requirements of the defined QMS and applicable regulatory standards, ensuring audits are performed effectively and objectively.
· Coordinate supplier corrective action requests (SCARs) in collaboration with Packing, Procurement, and QA teams to minimize supplier-related quality issues, and maintain accurate and up-to-date SCAR documentation and records.
· Monitor and evaluate the effectiveness of supplier corrective actions to ensure resolution of quality issues and prevent recurrence.
· Conduct hygiene audits in HGBU packing rooms as per the approved audit plan and report findings for corrective action.
· Continuously monitor, review, and follow up on departmental Risk and Opportunity Registers in coordination with process owners to support risk-based thinking and continual improvement initiatives.
· Prepare packing specification SOPs and ensure their implementation in the plant after artwork approval
· Provide support for external audits by ensuring the plant’s readiness and compliance with applicable requirements.
· Ensure to maintain the safe work area.
Maintain good house keeping practices, good manufacturing practices (GMP) , good hygiene practices (GHP) and 5S practices
· Contribute to QA projects
· Carry out any other duties assigned by the Senior Manager – QA, Assistant Manager – QA, and Specialist – QA.
What will you bring to Ansell?
Education
· B.Sc Degree or equivalent
· Internal auditor certificate in ISO 9001:2015 (Quality Management System) Requirements
· Diploma in Quality Management
Job Experience
At least 3-5 years experience in Quality Assurance
Knowledge & Skills
· High degree of computer literacy
· Data analysis and report preparation
· Preparation of presentation slides
· Internal auditing skill
Desirable Job Competencies
· Good interpersonal and presentation skills.
· Ability to interact effectively with internal and external customers at all levels and develop strong working relationships.
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