Australia
I have more than 15 years of experience in the Risk & Quality function which includes supplier quality management, customer complaint management, development & manufacturing quality as well as change management process. I am experienced in setting up QMS both internally and externally (at suppliers) and am adept with the DFSS approach. I have experience in the R&D/manufacturing industry in Malaysia, Singapore, Australia and France with more than a decade in Australia. • Skilled in Design for Six Sigma (DFSS)/DMAIC and Lean/Continuous Improvement via gap analysis to identify improvement opportunities – Green Belt-trained • Expert in setting up Quality Management Systems (QMS) as well as conducting trainings (internal and external) • Skilled at conducting audits (internal and external) according to industry standards (ISO9001, TS16949) • Expert in Quality tools – 8 Discipline (8D), Failure Modes and Effects Analysis (FMEA), Voice of Customer (VoC), Design of Experiment (DOE), risk assessment, statistical analysis, etc. • Experienced in setting up quality system at suppliers/ODMs from documentation level to manufacturing line based on APQP approach (MQS/PPAP) • Skilled in managing customer feedback/recall e.g. communication with customers, rootcause analysis on customer complaints, lessons learnt feedback loop • Expert in problem solving e.g. 5Whys, Red X, fault tree and managing NCRs • Expert in designing test protocols to simulate use case scenario e.g. reliability testing, stress testing as well as experience with safety testing based on IEC standards (IEC 60335, IEC 60669, etc.) • Supervisory experience on quality team and laboratory management as well as OH&S participation • Computer proficient: MS Office (Word, Excel, PowerPoint, Project) and other software tools (Weibull, ALTA ,Minitab)
- Comprehensive supply chain mapping to identify dependencies, vulnerabilities, and critical nodes to ensure the availability and continuity of essential components within our supply chain. - Manage these components and mitigate associated risks to maintain a resilient and efficient supply chain. - Utilise data-driven approaches to identify risks and collaborate with various departments to manage projects aimed at mitigating these risks effectively. - Developing and implementing strategies to gather, process, and analyse data, working closely with cross-functional teams to provide actionable insights that support our commitment to a resilient supply chain.
o Develop, implement, maintain and improve Nanosonics’ Quality Management System (QMS) processes relating to e.g. Change Control, Control of Nonconforming Product, CAPA, QMS Computer Systems validation, New Product Introduction in accordance with the appropriate standards and requirements (including EN ISO 13485, MDD/MDR and FDA CFR 21 820) to ensure regulatory compliance. o Participate in the design and development and New Product Introduction processes and ensure QA requirements are communicated and met. o Participate in the internal and external audit programs o Provide subject matter expertise with regard to Nanosonics QMS, EN/ISO 13485, MDR and FDA QSR requirements.
o Implementing long term strategic quality improvement planning via supplier quality assessment and audits o Reduced supplier-related field returns by 20% via Continuous Improvement activities on supplier quality issues and assist in problem-solving & root cause analysis via CAPA) o Decreased supplier-related issues from Production complaints by 25% by having monthly reviews on critical suppliers thereby improving line productivity o Continuous Improvement of ATI product design and supplier quality performance with monthly reviews of key supplier metrics o Translate critical-to-quality characteristics to production and suppliers o Standardising Supplier Quality processes & procedures o SME in eQMS (Trackvia, ETQ) and successfully launching ETQ within organisation for non-conformance reporting
- Managing release of products e.g. cookware, toys, seasonal, arts & craft, stationeries, pet accessories, travelgoods from quality and safety aspects as well as functionality and reliability - Subject matter expert for above categories and partner closely with the local and Asia based Design, Buying, Sourcing and Quality Teams to ensure that Australia Standard is met - Stipulating quality (test) requirements for new products based on customer usage, competitor benchmarking, predecessor products - Liaising with purchasing and suppliers to ensure conformance to NPD process and drive quality mindset - Continuously monitor product quality via Pre-Shipment Inspection for high-risk items - Handling customer complaints via rootcause finding as well as managing product withdrawals and recalls via ACCC - Executing store surveillance to ensure no discrepancies/abnormalities on products sold vs. released products
o Assist and coach project team on quality tools based on DFSS approach o Developing and executing the design release verification and validation plan o Responsible for product safety, compliance, regulatory, sustainability and approbation related activities. o Steer for robust and reliable design, driving capability and reliability requirements. o Manage risk, facilitate and review FMEA’s, Problem/Issues logs. o Design and execute Quality Test Plan ( product reliability and performance) o Manage supplier quality control (ODM) via MQS/PPAP during project development o Provide advice based on the Quality information available during the milestone meeting and mandatory advice the stakeholders if the criteria are not met to pass the project Milestone. o Provide an interface between the project team members (including Supplier Quality Leader, Technical Project Leader and the Project Leader, on product quality aspects.