Supplier Quality Engineer II, Fresenius USA Manufacturing, Inc., a Fresenius Medical Care N.A. company, Lexington, MA (Remote) **Job Duties:** Responsible for assuring End-to-End quality and sustainability with allocated supply base, validating, and releasing components, and supporting the definition and implementation of supplier quality functional excellence initiatives. Specific duties include: + Interfacing directly with suppliers to follow up on quality and performance issues, managing Supplier Corrective Action Requests. + Performing on-site and remote supplier quality audits for new suppliers, participating in supplier approval process. + Documenting and following up on audit results and required actions to be addressed by the supplier. + Tracking, analyzing and reporting on supplier performance metrics to stakeholders within quality, logistics and manufacturing management using the appropriate software tools. + Performing problem analysis, process and machine capability studies as required, and determining and proposing statistical process controls for appropriate supplier’s processes. + Collaborating with stakeholders to define deliverables meeting user needs and acceptance criteria. + Ensuring documentation is aligned with corporate standards including FMEA, DFMEA, Manufacturing Process Characterization / PFMEA, product life cycles. + Performing gap analysis of Design Control Quality System, determined changes required to close gaps, and implement changes. + Preparing Supplier Corrective Action Reports (SCARs) and Supplier Nonconformance Reports (SNCs), interfacing with both internal customers and the supply base to ensure effective actions are taken to reach closure. + Execute Supplied Part Approval Process including providing supplier with required deliverables, then reviewing and approving these deliverables. + Review and update Supplier Quality SOPs using Quality tools and principles. **Requirements** **:** Position requires either a Bachelor’s degree (or an equivalent foreign degree) in Industrial Engineering, Pharmaceutical Engineering, Pharmacy or a related life sciences field and 5 years of experience as a Quality Engineer working in the medical device or pharmaceutical sector or alternatively, a Master’s degree(or an equivalent foreign degree) in Industrial Engineering, Pharmaceutical Engineering, Pharmacy or a related life science field and 3 years of experience as a Quality Engineer working in the medical device or pharmaceutical sector. Must also have had 3 years of experience (which can have been gained concurrently with either of the primary experience requirements above) working with the following: + Performing on-site and remote supplier quality audits and participating in the supplier selection and approval process; + Tracking, analyzing, and reporting supplier performance metrics to internal stakeholders within quality, logistics, and manufacturing management using the appropriate software tools; + Maintaining Risk Management files including Hazard analysis, Design FMEA, Use FMEA and Process FMEA for assigned product families; + Utilizing Root Cause Analysis concepts to investigate issues and implement Corrective and Preventive actions including effectiveness checks. + Performing Design of Experiments (DoE) using Minitab and analyzing various process parameters with the use of statistical tools (SPC) such as Gage R & R, Gage linearity and Bias study, interaction plot, process capability study to optimize the blending and compression process. This position requires approximately 10% domestic and international travel. This is a telecommuting position working from home. May reside anywhere in the United States. Salary is $163,030 - $171,181 per year for a 40-hour work week. **EOE, disability/veterans**