Supplier Quality Engineer II

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