Job Description

Ansell is a leading global provider of protection solutions. Our company designs, develops and manufactures a wide range of protection solutions that meet the ever-changing needs and demands of our markets and industries. Protection is our primary concern as millions of people around the world depend on Ansell in their professional and personal lives.

Our vision is to create a world where people can enjoy optimal protection against the risk they are exposed to. Whether at work or during their leisure time, people require the right protection for the right application. After all, what better guarantee is there than increased safety, security and productivity than through adequate protection.

GENERAL SUMMARY OF POSITION

Carry out QA activities as assigned in Sourcing HGBU and in supporting organizational goals. 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 product specification creation /revision, COA review, prepare inspection schedule, multi-sources product evaluation and trending analysis, calibration of QA inspection sampling and inspection, coordinating Change Control and implementation process and/or as assigned by QA Manager and/or QARA Director. This position will also provide supervision and guidance to QA members that to be results-driven, and ready to coach, mentor and build successful talent pipeline for the QA organization, cultivating a high performing culture.

RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES

• Perform onsite /virtual inspection and testing of finished product to ensure conformance to the agreed specifications, and maintain appropriate records.
• 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 inhouse lab results and assist in identifying and correcting unexplained data discrepancies
• Identify production that deviates from historical trends, even if it still is 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
• 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 finding.
• 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 highlighting product performance variation of new sourcing options or new potential products.
• 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 highlighting product variation if any.
• 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.
• In order to ensure consistency and mitigate variation in QA inspection, every QA shall carry out inspection/surveillance steps as per SOP the same way and consistent (i.e. sampling method and test method), so in order to further assure this integrity, QAM and/or Sr. Specialist (as assigned by QAM or QA Director) shall calibrate each QA (onsite and/or virtual) routinely.
• 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 requirement.
• Other QA task(s) as assigned by QA Manager and/or Director.

KEY POSITION REQUIREMENTS

Education

• Bachelor Degree or equivalent collage education (in chemistry /polymer science) preferred

Job Experience

• 3-5 years working experience in Quality Management System (manufacturing) ISO9001, ISO13485 and MDSAP, US FDA QSR and CFR 21, and Supplier QARA Management Systems.
• 3-5 years 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.
• 3-5 years working experience in Glove manufacturing /Glove R&D preferred.

Knowledge and Skills

• Good communication skills
• High Computer Literacy, specifically in MS Excel (particularly data trending and analysis), MS Word, MS PowerPoint, MS Access experience

*The position requires frequent travelling.