Supplier Quality Engineer

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Our Molecular Imaging business line has an exciting opening for a talented and experienced Quality Engineer.

This position reports directly into our Manager of Supplier Quality. The successful candidate will be instrumental in shaping the supplier quality organization in ensuring that our products continue to meet or exceed customer requirements and that organizational quality objectives are satisfied which are consistent with regulatory requirements and business objectives.

You will work cross-functionally in some cases, working to ensure that the supply chain is fully qualified before product release. In other cases, you will drive your own initiatives. You will contribute to and be exposed to knowledge sharing activities across different disciplines.

What You Will Do:

• Work closely with Engineering, Purchasing and suppliers to establish new product qualification criteria and define, support, and implement supplier quality plans and first article inspections (FAI).
• Collaborate with Engineering and review requirements with suppliers to ensure technical requirements are clearly understood.
• Validate that any engineering deviations and substitutions are approved and documented.
• Approve, develop and manage all direct and indirect quality relevant material suppliers, and ensure the material received from them is conforming
• 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 staff as needed.
• Conduct audits at supplier sites to qualify the supplier’s management system and manufacturing capabilities. Provide risk analysis and mitigation plans to address any gaps.
• Develop and maintain supplier performance KPl'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 responses from suppliers to formal corrective action requests (SCARs) for thoroughness and effectiveness.
• Proficiently use 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 (CAPA)
• Accompany and support customers during external reference site visits
• Participate in the knowledge exchange with our R&D team to improve and further develop our products and software solutions

Primary Requirements:

• BS degree in Electrical & Electronics / Mechanical Engineering 
• 5+ years of progressively responsible experience in a quality discipline or related field, and successful demonstration of key responsibilities and job knowledge.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers

• 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 9001
• Received training and successfully implemented quality assurance methodology to analyze and control key process parameters (Six Sigma, SPC, gage R&R, FMEA, and Poka -Yoke, etc.)
• Proficient with Microsoft Office with emphasis on EXCEL. Minitab experience would be a plus

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