Supplier Quality Engineer

Consultant, Medical Device, Supplier Quality Engineer Summary Our client, a growing medical device company, has engaged GForce Life Sciences, to identify a Supplier Quality Engineer to assist with ongoing baseline business. Duties / Expectations of Role The Supplier Quality Engineer should be familiar with quality functions, process flows, control plans, build instructions, process verification and validations (IQ/OQ/PQ), and quality inspection. Manager Supplier Change requests and initiate Supplier Change Control Processes Track CRF Responses Validating document testing, process flow and document regulations Work on supplier quality contracts Prepare draft Quality and Technical Agreements for existing and new suppliers Work closely with other HCL team working on ECRO process, used to archive the Supplier Quality contract in SAP system. Manage Change requests impacting supplier quality contracts Assisting with Supplier Selection and Qualification Assisting with SCARs, Audits, and Supplier Performance Support the Approved Supplier List maintenance/updates Ensure suppliers are compliant via objective evidence/documentation gathered over the course of the project using Client supplier qualification process such as SPPA/PPAP. Mandatory Requirements Bachelor of Science in Engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE). 3-7+ years of experience in a Quality Engineering role within Medical Device Experience working in a Supplier Quality or Continuity environment Working understanding of QSR/ISO regulations, design assurance, FMEA, Process Flow, and product testing methods. Experience in process validations: creating, reviewing, and approving protocols and reports, and execution of protocols. Experience with PPAP and Gage R&R Experience to include all components of production and process controls including, IQ, OQ, PQ, PPQ, manufacturing equipment software (CSV), and TMV/MSA. Term & Start 3+ months contract Start in April Onsite/Hybrid in Franklin Lakes, NJ preferred Benefits included (Medical, Dental, Vision, 401k) #J-18808-Ljbffr