Assoc Specialist, Quality Management

Job Description - Assoc Specialist, Quality Management (30010160) Description Why Ansell? At Ansell, by staying two steps ahead of workplace risk we aim 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 in industrial, medical, and consumer applications. Ansell is looking for an Assoc Specialist, Quality to join our team in Cyberjaya. In this position, you will be responsible for assisting the Associate Director QA EMAP in ensuring quality compliance to the applicable standards. The role will provide support in the development and maintenance of the quality management system for AHE/ANZ, Nitritex, and India and will provide administrative support to the regional QA team department. What your role will be? Collaborating with our cross-functional teams, you will have the opportunity to:

• Be a point of contact for quality product complaints ensuring that the customer experience is positive with a high level of customer centricity. a. Coordinate the return of product samples to the relevant factory/supplier, assist in the successful resolution of product quality; b. Log complaints into TrackWise Digital/One Link Module, advising Regulatory Affairs of any potential adverse event or medical device reportable incident; c. Approve replacement and credit refunds through COMIND up to 5,000 Euro; d. Continuously monitor and report on complaint trends developing. e. Liaise with the applicable QA Plant leads throughout the process of the customer feedback management process.
• Support the Associate Director QA EMAP to ensure accurate, timely, and completed documented information for the applicable quality management systems through One Link in preparation for any external, announced, or internal audits.
• Coordinate the status of quality product returns from quality product complaints received from the return of quality issues into the applicable warehouses. Support any quarantine stock to be placed into quarantine at the applicable warehouses, ensuring that all applicable internal stakeholders are aware of products placed into quarantine.
• Continually appraise the Associate Director QA EMAP on matters of importance in the incumbent’s area of responsibility that may impact the business, or which is necessary to meet the required objectives.
• Provide technical support to the customer i.e. questionnaires, statements, CoA/CoC, sustainability requests, etc.
• Participate in any QA meetings with members of the regional QA team.
• Act as backup support for other regional QA team members during times of absence.
• Perform any other duties as requested by the Associate Director QA EMAP.

What will you bring to Ansell?

• University Degree or equivalent related business experience;
• ISO 9001, ISO 13485 and Medical Device Regulations knowledge;
• 2 years of experience in working in an administrative support environment in either quality or regulatory affairs;
• Knowledge and exposure to the regulatory requirements for medical devices.

Join us to lead the world to a safer future, apply today! Equal Opportunity Employer Ansell commits to securing an equal opportunity recruitment and selection process. All interested candidates are encouraged to apply and will receive consideration for employment regardless of age, sex, gender identity, sexual orientation, race, color, ethnic origin, religion, disability, genetic information, or any other factors that could be deemed discriminatory. Our Commitment to Diversity Equity and Inclusion Ansell’s vision is about creating safe spaces where diverse perspectives are valued alongside individual contributions. It is our view that togetherness prevails over individuality.

Primary Location

Work Locations

MY Selangor Cyberjaya Prima 6 Prima Avenue Block 3512 Prima 6 Prima Avenue, Block 3512 Jalan Teknokrat 6 Cyberjaya 63000#J-18808-Ljbffr