Participates in formulating quality programs, plans, procedures and practices. Performs semi-complex statistical analysis as related to product and material quality. Supports in the analysis of defective material and leads in the final disposition of defective material through the material review board process. Analyze production and material review board data to determine trends to initiate corrective action and identify continuous improvement opportunities. Conducts semi-complex audits of supplier quality system or manufacturing processes to determine compliance with our quality requirements. Provides monthly performance input to the supplier rating system. Provides input during new supplier evaluation to determine suitability for inclusion to the Approved Supplier List ( ASL). Maintains the required views in the SAP ERP system including inspection planning. Provides technical in-put, training and guidance to inspectors.
Primary responsibilities include the approval, development and management of all direct and indirect quality relevant material suppliers, and to ensure the material received from them is conforming.
Work cross-functionally in support of product development to ensure that that the supply chain is fully qualified before product release.
Review design specifications and develop material inspection plans within the SAP ERP system to be used incoming inspection personnel to assess the conformance of received material. Provide assistance and guidance to inspection personnel as needed.
Develop and maintain supplier performance KPI’s and utilize them assess quality trends, performance target setting and verify effectiveness of implemented corrective action plans.
Analyze the complexities and interrelationships of non-conforming material situations and determine the root cause as well what an effective corrective action plan would entail. Evaluate 8D responses from suppliers to formal corrective action requests (SCARs) for thoroughness and effectiveness.
Proficiently use of basic statistical analysis methods and practices to analyze processes and corrective action plans to determine the state of control or effectiveness.
Conduct on site supplier QMS and or process audits and drive corrective action plans
Excellent decision making abilities showing awareness of risk and regulatory requirements. Able to evaluate options and solutions while using good judgment.
Required Knowledge/Skills, Education, and Experience
Must have an accumulated 5 to 10 years of successful experience in quality disciplines or related field, and successful demonstration of key responsibilities and job knowledge. Must have a BS degree in a technical field, ME, EE, or IE preferred.
Preferred Knowledge/Skills, Education, and Experience
Experienced in performing both quality system and product audits performed at a supplier or subcontractor facility both domestic and internationally. Have obtained sufficient audit training from an accredited source (ASQ or ANSI-RAB NAP) resulting in an ASQ-CQA or RAB certification.
Achieved and maintained ASQ-CQE certification
Knowledge / training of ISO 13485 and ISO 9000
Received training and successfully implemented quality assurance methodology to analyze and control key process parameters (Six Sigma, SPC, gage R&R, FMEA, and Poke –Yoke, etc.)
Proficient with Microsoft Office with emphasis on EXCEL. Minitab experience would be a plus.
Job ID: 181555
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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