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 manufactu...