 Finish QMS internal surveillance audits including NCMR process, production inspect/test & vendor management. Develop audit checklists, recorded observations, wrote audit reports, conduct internal audit open/close meetings. Manage CAPA progress in Arena, issued deviations/extensions; perform root cause investigation w/effectivity check. Supervised incoming inspection; approved disposition & rework of NCMR’s; track NCMR/IIR/RMP closure in Arena. Resolve discrepant materials at incoming & in-process inspection. Enforce supplier quality agreements issue SCARs. Built Excel formulas into KPI metrics/charts, parse data via pivot tables by categories. Develop supplier score card.

 Conduct failure analysis on product returned; dissected & analyse damage/fragments reconstructing failure mode.  Edit customer response detailing investigation findings to verify warranty claim and update FMEA’s failure mode. Led root cause 5 WHY investigation for stapler/sleeve lack-of-fit. Lead for LEAN/5-S for blade grinding/assembly. Brainstorming with cleanroom leads/techs for root cause investigation of contaminant in customer return pouches.  Edit validation protocol/report of over-mould hub surgical cutting tips. Develop control plans to monitor critical dim’s

 Create 40 pFMECA’s of electro-mechanical assemblies from component build diagrams, transcribe assembly-build instructions into process failure mode, identify causes and adverse effects exhibited by the process. Revise hazard analysis of electrical grounding/EMI component interfaces during transfer of design to production.  Edit assembly/build instructions w/CREO visual aids for pilot assembly build.

 Identify user needs via customer meetings, draft concise design input specifications. Map design inputs to dFMEA to mitigate and control risk with traceability matrix for blood syringe, split septum valves and oncology capsules. Complete Gage R&R for initial production runs; ran PPAP testing, MSA’s, flow diagram, FMEA’s, control plans. Responsible for SAT/FAT of laser welder; edit validation protocol with DOE optimization of best weld settings. Completed CAPA’s with corrective actions assigned for chronic/systemic process changes. Authored ECN/DCN’s.  Set up catheter IVD cassette/tubing production line; create VISIO diagrams of process flow through assembly.

 Author of a comprehensive Shelf Life/Stability SOP. Led cross functional stages reviews for completion of the SOP. Research standards ISO 11607, ISO 10993, ASTM F-1980, ICH Q1A/D/E; incorporate compliancy needful into SOP.