Specialist, y Assurance

Why Ansell?

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well-being. The world's need for better protection never stops, so Ansell is constantly researching, developing and investing to manufacture and distribute cutting-edge product innovation and technology, marketed under well-known brands that customers trust. Operating in two main business segments, Industrial and Healthcare, Ansell is the market leader that continues to grow, employing 14,000 people worldwide.

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

Ansell is looking for a Quality Assurance Specialist to join our team in Cyberjaya.

In this role, you will assist the QA Manager in managing the Raw Material Supplier Management Program in supporting organizational goals. In addition, this position will be responsible for onsite/virtual product inspection/audit, supplier audit, product sample evaluation and side-by-side comparison, and additional assignments such as multi-sources product evaluation and trending analysis, COA review, coordinating Change Control and implementation process, and/or as assigned by the QA Manager and/or QARA Director.

What you can expect from Ansell?

• Work for a world leader in the health and safety protection solutions industry.
• A secure workplace with competitive remuneration and annual bonus based on own and company performance.
• Flexible schedule with a combination of home and office-based working.
• Inclusive, collaborative, and supportive work atmosphere.
• A diverse and international work environment.

What your role will be in detail?

Collaborating with our cross-functional teams, and reporting to the Manager, QA, you will have the opportunity to:

1. Raw Material Supplier Management Program:
   Manage and maintain the execution of the Raw Material Supplier Management Program. This includes:
   
   1. Maintain updated Raw Material Supplier master listing.
   2. Follow up with Global sourcing and in-house plant on the Raw Material Supplier master listing information.
   3. Maintain and update List of qualified auditors, training records, etc.
   4. Upkeep audit plan and audit schedule status to ensure audits are conducted by competent auditors and are on schedule/revise schedule.
   5. Follow up and track to ensure auditors upload the required audit details (audit plan, audit checklist, completed audit report, etc.) in the shared portal.
   6. Assess effective implementation and maintenance of suppliers' Quality Management System based on applicable ISO standards and related regulatory requirements.
   7. Ability to analyse, monitor, and make comments/recommendations on the Raw Material Supplier Management Program.
2. Onsite/Virtual Product Inspection/Surveillance/Audit:
   Perform product inspections and Quality audits of Ansell's Manufacturing Partners. The duties include:
   
   1. Perform onsite/virtual inspection and testing of finished products to ensure conformance to the agreed specifications and maintain appropriate records.
   2. The testing includes (but is not limited to):
      • Water leak test
      • Physical dimension measurements (length, width, thickness & weight)
      • Physical properties measurements (Elongation, Modulus, Tensile Strength, Force at break)
      • Visual inspection (glove and packaging)
      • Packaging & labeling Quality
      • Packing quality
      • Glove durability test
      • White residue/IPA and Foaming test
      • Container loading (as needed)
      • Ash (filler check) to be performed by SA lab.
      • Etc. (as assigned by QA Manager/Director, from time to time)
   3. Analyse test results of supplier's Certificate of Analysis.
   4. Prepare trending charts for routine monitoring & conduct comparison analysis.
   5. Analyse test results and trends and make comments and recommendations.
   6. Prepare inspection reports and update quality dashboard.
   7. When necessary, correlate local/factory test results with in-house lab results and assist in identifying and correcting unexplained data discrepancies.
   8. Identify production that deviates from historical trends, even if it still is within specification.
   9. Work onsite with Manufacturing Partners to correct product quality and/or manufacturing process-related issues, including onsite verification of corrective actions triggered from PQC/SCAR.
   10. Work on special projects as needed.
3. Supplier Audit:
   Perform suppliers' quality system audit and/or surveillance per ISO 9001, ISO 13485, US FDA 21 CFR 820 Quality System Regulation and Canada Medical Device Regulation SOR/98-282. Work with Manufacturing Partners to correct product quality and/or manufacturing process-related issues, including onsite verification of corrective actions triggered from supplier audit findings.
4. Sample Evaluation:
   Assist in the product evaluation/qualification and set-up of new products and/or new suppliers. Perform product testing, provide side-by-side product comparison reports, provide analysis comments/recommendations, and highlight product performance variation of new sourcing options or new potential products.
5. Sample Evaluation – Multi-sources Product:
   Assist in the product evaluation, comparison, and trending analysis of multi-sources products. Perform product testing, provide side-by-side product comparison reports, provide analysis comments/recommendations, and highlight product variation if any.
6. Change Control:
   Coordinate suppliers' change requests by initiating Change Control records in TWD, coordinate with PPM, RA, QA, and MP to ensure the required aspects are carried out, reviewed, and approved prior to implementation. Compile the necessary supporting test reports and documentation for CRB review/approval and carry out verification/effectiveness check of the change.
7. COA Review:
   To review Certificate of Analysis (COA) as assigned, to ensure the shipment goods conform to the product specification. Sign off COA and report OOS/OOC (if any) to QAM.
8. Other QA task(s) as assigned by QA Manager and/or Director.

What will you bring?

• Bachelor Degree or equivalent college education (in chemistry/polymer science) preferred; High School education accepted with sufficient work experience in QA, RA and QMS management.
• Working experience in Quality Management System (manufacturing) ISO 9001, ISO 13485 and MDSAP, US FDA QSR and CFR 21, and Supplier QARA Management Systems.
• Working experience in Medical Device QARA i.e. EN MDR and PPE regulations, all regional/country MD regulations including gloves standards i.e., ASTM, EN, ISO, JIS, TGA, GB & etc.
• Working experience in Glove manufacturing/Glove R&D preferred.
• Communicate fluently (oral & written) in English (required). Bahasa Malaysia (preferred), Chinese/Mandarin (preferred).
• Good written English with technical writing/reporting skills.
• High Computer Literacy, specifically in MS Excel (particularly data trending and analysis), MS Word, MS PowerPoint, MS Access experience also preferred.
• Analytical thinking and problem-solving ability.
• Ability to analyse & make comments/recommendations.
• Able to work independently with minimal supervision.
• Flexible in job rotation.
• The position requires some travel to multiple manufacturing locations throughout Malaysia, with occasional travel to Indonesia, China, Thailand, Vietnam & Sri Lanka.
• 60% of the position's time will be spent on-site at these manufacturing partner locations.