Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as a Quality Engineer. This position is located at Hoffman Estates, IL.
You will be responsible for formulating quality programs, plans, procedures, and practices. Perform semi- complex statistical analysis as related to product and material quality. Support in the analysis of defective material and leads to 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 actions and identify continuous improvement opportunities. Conduct semi-complex audits of supplier quality system or manufacturing processes to determine compliance with our quality regulations. Provide monthly performance input to supplier rating system. Provide input during new supplier evaluation to determine suitability for inclusion of Approved Supplier List (ASL). Maintains the required views in SAP ERP system including inspection planning. Provides technical in-put, training, and guidance to inspectors.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Engineer, you will be responsible for:
- Approval, development, and management of all direct and indirect quality relevant material suppliers, and to ensure the material received is conforming
- Work cross functionally in support of product development to ensure 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
- Develop and maintain supplier performance KPI’s and assess quality trends, performance target setting and verify effectiveness of implemented corrective actions plans
- Analyze the complexities and interrelationships of non conforming material situations and determine the root cause as well as what an effective corrective action plan would entail. Evaluate 8D responses from suppliers to form corrective action requests (SCARS) for thoroughness and effectiveness
- Proficiently use the 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. Ability to evaluate options and solutions while using good judgement
Required skills to have for the success of this role
- 5-10 plus years of experience in quality or related discipline
- Bachelors Degree in a technical field (ME, EE, IE preferred)
Preferred skills to have for the success of this role
- Experience performing both quality system and product audits performed at a supplier or subcontractor facility both domestic and internationally
- 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 and 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, Poke-Yoke)
- Proficient in Microsoft Office with emphasis on Excel. Minitab experience is a plus
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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