Job
Description
Purpose of Function This position is responsible for delivering all aspects of the Supplier Quality Assurance function. Ensuring the product quality of supplier manufactured products & processes. Responsible for ensuring that the products produced meet quality standards required to minimize quality costs and maximized customer satisfaction whilst ensuring that procedures and processes are adhered to, Tasks and Responsibilities Support new product launches to ensure that supplier quality meets the required. Prepared and analyze supplier evaluation and audits, and take appropriate actions where evaluation results out of target. Performed Supplier improvement program for key suppliers and monitor progress to achieve 1000 ppm. Work with Engineering (Design and Manufacturing Engineers) team to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements. Lead the supplier approval process by assessing manufacturing/technology capabilities and Health, Safety and Environmental risks. Good knowledge and hands on experience in conducting technical audits/process audits for plating, powder coating, special process and achieve target ppm. Good knowledge and hands on experience in inspection of mechanical components like Casting, Seals, Plastics, Sheet metal, Cables, PCBA’s commodities. Perform Quality systems, Technical and Process audits at suppliers’ place. Part qualification through PPAP (FAI) process and perform process qualification audits for critical components. Perform SPC/SQC for key products and processes. Facilitate SCAR / CAPA and Perform on-site supplier visits for root cause analysis and verification of correction actions of supplier quality issues. Collate and evaluate supplier quality data to identify process improvement opportunities within the supply chain Work with the supplier directly, create correction action plans to address process failures. Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities. Promote the use of customer preferred techniques for continuous Improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis, and Process Failure Mode and Effects analysis. (PFMEA). Provide concise, complete and accurate documentation of inspection. Results relative to area of responsibility. In appropriate functional areas. This refers to supporting inspection and test status requirements defined by regulations, engineering product specifications or Control Plans. Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers. Support the Quality Manager to monitor and report on supplier product quality and performance. Hands on experience in preparing and review control plans for manufacture processes. Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system. Perform First Article inspection and sample approvals. Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements! Contribute to continuous improvement activities. Quality control of work by appropriate reviews Stay current and up to date on any changes that may affect the supply and demand of needed products and materials and advise others of any Impact. Support technicians and engineers. Communicate efficiently throughout the shop floor and with own and customer’s management. Liaise and communicate with other departments, customers, suppliers and other service providers. Support in Quality process implementation and internal audits. Education Engineering Degree/Diploma in Mechanical Related Experience 7 to 10 years of working experience in manufacturing industry preferably medical devices. Experience of working in Quality Assurance Experience of Supplier quality developments ( Audits, Improvements, Part Qualification, Performance monitoring for suppliers ) Experience of dealing with customers and suppliers Experience in testing, calibration, and documentation Skills & Attributes: Knowledge of quality and business systems Knowledge of Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode and Effect Analysis (FMEA),SPC,SQC Knowledge of CE Marking, ROHS,REACH requirements Knowledge of ISO 9001/13485 Knowledge of ISO45001/14001 Knowledge of measurement techniques Metrology, Inspection Methods and Equipment Knowledge of Six sigma method – DMAIC Understanding and interpretation of engineering drawings Understanding manufacturing processes. General Competencies - Good communication and interpersonal skills Logical & Rational Tactful Result oriented. Attention to details. Team player Show more Show less
