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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