General Summary Of The Position 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, as assigned by QA Manager and/or QARA Director. What would your role look like Reporting to Sr Manager or Director, you will be: 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 not limited to): Water leak test ii. Physical dimension measurements (length, width, thickness & weight) iii. Physical properties measurements (Elongation, Modulus, Tensile Strength, Force at break) iv. Visual inspection (glove and packaging) Packaging & labelling Quality vi. Packing quality vii. Glove durability test viii. White residue /IPA and Foaming test ix. Container loading (as needed) Ash (filler check) to be performed by SA lab xi. 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 localfactory 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 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 finding. 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 highlighting product performance variation of new sourcing options or new potential products. 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 highlighting product variation if any. 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. COA review To review Certificate of Analysis (COA) as assigned, to ensure the shipment goods conforms to the product specification. Sign off COA and report OOS/OOC (if any) to QAM. Other QA task(s) as assigned by QA Manager and/or Director. What you will bring: Minimum 3 years of working experience in compliance and auditing background. (Quality assurance is preferred.) Fresh graduates are welcome to apply. Computer literate and familiar with MS office application software e.g words, Excel, Powder point and other software like Adobe. Hands-on experience with Quality System Standards is preferred. Gloves manufacturing processes background is advantaged. Good knowledge in ISO 9001 & ISO 13485 Quality System requirement. Travel with flexible schedule and short timeline notification whenever necessary. Be accurate, precise and reliable in evaluating the testing data against established product specification. Good written and oral communication skill. Primary Location Malaysia-Selangor-Cyberjaya Work Locations MY Selangor Cyberjaya Prima 6 Prima Avenue Block 3512 Job Quality Organization Global Product & Marketing Schedule Full-time Job Type Standard Job Level Analyst Travel Yes, 75 % of the Time Job Posting Feb 16, 2024, 6:21:27 AM
