Quality Assurance Specialist

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 here.

Ansell is looking for a QA Outsource Product QA Specialist to join our team in Cyberjaya.

In this role, you will carry out QA activities as assigned in supporting organizational goals. This position will be responsible for onsite/virtual product inspection/audit, supplier audit, product sample evaluation, 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 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 details?

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

1. Onsite/Virtual Product Inspection/Surveillance/Audit:

• Perform product inspections and Quality audits of Ansell’s Manufacturing Partners. The duties include:
• Perform onsite/virtual inspection and testing of finished product to ensure conformance to the agreed specifications, and maintain appropriate records.
• 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 & labelling 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)
• Analyse test results of supplier’s Certificate of Analysis
• Prepare trending charts for routine monitoring & conduct comparison analysis
• Analyse test results and trends, and make comments and recommendations
• Prepare inspection report and update quality dashboard
• When necessary correlate local/factory test results with in-house lab results and assist in identifying and correcting unexplained data discrepancies
• Identify production that deviates from historical trends, even if it is still within specification
• 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.
• Work on special projects as needed

2. Supplier Audit:

• Perform suppliers’ quality system audit and/or surveillance per ISO 9001, ISO13485, 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.

3. 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.

4. Change Control:

• Coordinate suppliers’ change request by initiating Change Control record 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.

5. Product Specification:

• Assist QA Manager in establishing, documenting and maintaining product specifications (PS) for outsource HGBU finished products. And assist QA Manager in capturing change/update per Standards (i.e. ASTM, EN, ISO, JIS, GB & etc. – product/inspection requirement, acceptance criteria, sampling plan, test methods and etc.) from time to time, and update PS accordingly.
• Liaise with marketing, technical, GBU, regulatory, artwork team for the approvals of product specification to ensure compliance to regulatory and customer requirements.

6. Technical/Product Information and Support:

• As assigned by QA Manager, compile and maintain suppliers’ product technical files for medical products, to support regional QARA and Scientific Affairs in MDR technical file maintenance per EU MDR and MDSAP.
• As assigned by QA Manager, compile and maintain suppliers’ product technical files for non-medical products, to support regional QARA per EU PPE requirement and per Ansell requirements.
• As assigned by QA Manager, provide technical support to regional marketing and regional QARA for tendering activities and customers’ questionnaires.
• As assigned by QA Manager, liaise with regional QARA and suppliers for product registration and NPD projects, or any resources requirement for effective implementation of the system whenever necessary.
• As assigned by QA Manager, maintain routine test/monitoring requirements i.e. Sterilization dose audit for sterile products, bioburden for non-sterile products, Silicone/FTIR, Glycerol content, Product Conformance test to EN455, etc. Maintain test schedule and database of test results/reports.

7. Onsite Inspection Scheduling:

• Scheduling OQ team onsite/virtual/offsite product inspection and/or surveillance, rotating quarterly.

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) ISO9001, ISO13485 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