Supplier Quality Engineer

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Our Molecular Imaging business line has an exciting opening for a talented and experienced Supplier Quality Engineer focused on Suppliers and Products. This position reports directly onto 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 initiative. You will contribute to and be exposed to knowledge sharing activities across different disciplines.

You are responsible for:

• Working closely with Engineering, Purchasing, and suppliers to establish new product qualification criteria and defining, supporting, and implementing supplier quality plans and first article inspections (FAI)

• Collaborating with Engineering and reviewing requirements with suppliers to ensure technical requirements are clearly understood

• Validating that all engineering deviations and substitutions are properly approved and documented

• Approving, developing, and managing all direct and indirect quality-relevant material suppliers and ensuring received materials conform to specifications

• Reviewing design specifications and developing material inspection plans within SAP ERP for use by incoming inspection personnel to assess material conformance, while providing guidance and assistance as needed

• Conducting audits at supplier sites to qualify management systems and manufacturing capabilities and providing risk analyses and mitigation plans to address gaps

• Developing and maintaining supplier performance KPIs and utilizing them to assess quality trends, set performance targets, and verify the effectiveness of corrective actions

• Analyzing complex non-conforming material situations to determine root causes and defining effective corrective action plans, while evaluating supplier responses to SCARs for completeness and effectiveness

• Utilizing basic statistical analysis methods to evaluate processes and corrective actions to determine control status and overall effectiveness

• Conducting on-site supplier QMS or process audits and driving corrective and preventive action (CAPA) plans

• Accompanying and supporting customers during external reference site visits to ensure confidence in supplier and product quality

• Participating in knowledge exchange with R&D teams to continuously improve and further develop products and software solutions

Required Qualifications:

• 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 be a strong fit for you if you are familiar with the following and are eager to further develop your career with Siemens Healthineers:

• Demonstrating experience in conducting both quality system and product audits at supplier or subcontractor facilities, domestically and internationally

• Completing formal audit training from an accredited organization (ASQ or ANSI-RAB NAP) and holding an ASQ-CQA or RAB certification

• Achieving and maintaining ASQ-CQE certification

• Possessing in-depth knowledge and training in ISO 13485 and ISO 9001 standards

• Applying quality assurance methodologies such as Six Sigma, Statistical Process Control (SPC), Gage R&R, FMEA, and Poka-Yoke to analyze and control key process parameters

• Showing proficiency in Microsoft Office, with strong emphasis on Excel; experience with Minitab is a plus

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no mat