Mardalyna Salleh

Experience

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  CR Bard

  Jan 2005 - Jan 2013

  Sr. QA Supervisor

  - Perform evaluation on product quality, resolve quality problems and initiate corrective action with other departments as required.- Collection of quality data and procedure report to Management on trend analysis.- Train QC Inspector and Lead QC on work procedure and appraise their work periodically Supervise QC Inspector and activities for Incoming materials inspection and documentation.- Responsible for handling and documentation of incoming material acceptance and rejections according to approved procedures and specifications.- Responsible for item maintenance and issuance of components part numbers (Spec).- Develop and maintain all materials and component specifications.- Responsible for SCAR issuance and monitoring(SCAR coordinator).- Supervise the daily activities of QC Inspector and to train QC Inspector and lead QC on work procedures and appraise their work periodically.- Collection of quality data and produce report to management on trend analysis and resolve quality problems.- Involve in product solving issue. In charge on Quality issue on finished product before send out to customer.- To carry out special projects related to QA activities. Perform and qualify a new product introduce in Bard Sdn. Bhd.- Involve in new project introduce in Bard Malaysia and also transfer project from USA.- Be a QA Representative or Project Leader in Non Design Change and Design Change Project .- Involve in preparing and review documentation such as cert to release a product, project doumentation , protocol and report and also procedure on the QA Audit. - As a team member on Internal Quality Audit (IQA) and external audit (FDA, BSI, Medicon, ISO, Safety and etc).- Responsible to lead on Inventory under QA responsibility that conducted in Bard twice a year.- Ensure that documentation required for finished product release are prepared efficiently.- Responsible for the issuance of product item number and bill of material (BOM) for Finished Products. Tunjukkan kurang

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  Teleflex Medical Sdn Bhd

  Jan 2013 - Jan 2015

  Production Supervisor

  - Write up validation protocol and report for new Project Transfer (Unique) in Teleflex Sdn. Bhd.- Data collection, data analysis and decision making based on data.- Responsible on the process improvement and quality.- Develop new procedure, instruction, operation work instruction and forms for new Project Transfer (Unique) in Teleflex.- Revise operation documentation for current product in Teleflex Sdn Bhd- Responsible to perform investigation and answer the NC issue to production.- Investigate and troubleshoot mechanical and process related issue.- Work together with equipment and manufacturing department for improvement on new project transfer. - Train and coach technicians, supervisors and QA on all documentation related on the new - project transfer (Unique).- Train and coach technicians, supervisors and shift engineer on new transfer process. - Support, sustain and responsible in process enhancement and new process implementation. Tunjukkan kurang

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  JJSV Manufacturing Malaysia Sdn Bhd

  Jan 2015 - Nov 2018

  Quality Engineer

  - Support Operations Quality group and lead Product Release to ensure Quality and business objectives are met.- QA Representative for Manufacturing activities in back end process (Final Packaging).- Provide guidance for all Operations Quality decisions in AMO/JJSV Malaysia- Responsible for daily quality acceptance activities and make sure the products manufactured are complying with the established quality criteria. - Responsible to perform compliance audit against the product specification and the established SOP. - Participate in failure investigations within the manufacturing department and will assist with audits, regulatory assessments, and product complaint investigations/product impact analysis.- Reviews nonconforming events for manufacturing issues. Investigates field failures related to manufacturing processes. Supports the development of corrective action plan where necessary.- Assists in Product/Process improvement efforts (e.g). Scrap, nonconforming product, customer complains) by systematically gathering quality metric data and by assisting in the appropriated analysis methods to enhance sustaining product design. - Identifies Manufacturing process defects (scrap, nonconforming material, customer complaints) by disposition of nonconforming material, identifying primary root causes and suggesting corrective and preventive actions.- Supports line extension/ new product introduction project on matters related to QA Operations.- Write up Test Method Validation protocol and report for Visual Inspection of Acrylic One Piece Lenses (Model AAB00 and ZCB00)- Develop and revised Visual Aid for Production, Collect and establish Golden Samples (Reject and Accept Lens) for Production.- Involved on updating SKU’s and Routing for product transfer (Toric, Symfony and ICB00). Tunjukkan kurang

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  BD Bard Sdn Bhd

  Nov 2018 - now

  Quality Engineer Complaint BD Bard Sdn Bhd