Supplier Quality Engineer

Consultant, Medical Device, Supplier Quality EngineerSummaryOur 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 RoleThe 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 ProcessesTrack CRF ResponsesValidating document testing, process flow and document regulationsWork on supplier quality contractsPrepare draft Quality and Technical Agreements for existing and new suppliersWork 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 contractsAssisting with Supplier Selection and QualificationAssisting with SCARs, Audits, and Supplier PerformanceSupport the Approved Supplier List maintenance/updatesEnsure suppliers are compliant via objective evidence/documentation gathered over the course of the project using Client supplier qualification process such as SPPA/PPAP.Mandatory RequirementsBachelor 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 DeviceExperience working in a Supplier Quality or Continuity environmentWorking 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&RExperience to include all components of production and process controls including, IQ, OQ, PQ, PPQ, manufacturing equipment software (CSV), and TMV/MSA.Term & Start3+ months contractStart in AprilOnsite/Hybrid in Franklin Lakes, NJ preferredBenefits included (Medical, Dental, Vision, 401k)