As a Quality Manager at CEI, makers of blanking/progressive stampings, CNC Swiss/Lathe/Wire/Mill machined components/assemblies for the Medical, Dental, Aerospace, Automotive, Firearms, Defense, Commercial, Energy, and Consumer Industries, I am responsible for (1) establishing/maintaining a QMS to the standards CEI claims compliance too, (2) serve as the QMR, (3) managing the day-to-day QA activities (e.g., NCRs, CAPAs, Complaint Investigation/Resolution, RMAs, Internal Auditing, Supplier Controls, Supplier Audits, etc.) and QC activities including PPAPs (e.g., PFDs, PFMEAs, Control Plans, FAIs, MSA/Gage R&Rs (Minitab), CAP Studies (Minitab) with a quality team of 5, (4) reporting program metrics, KPIs, etc. to top management during management reviews, etc.

As a Director of Quality Assurance at CSS, makers of metal springs, blanking/progressive/fine blanked stampings, four slide, CNC Wire EDM/Mill machined components/assemblies for the Medical, Aerospace, Defense, Firearms, Transportation, and Consumer Industries, I am responsible for (1) establishing/ maintaining a QMS to the standards CEI claims compliance too, (2) serve as the QMR, (3) managing the day-to-day QA activities (e.g., NCRs, CAPAs, Complaints, RMAs, Internal Auditing, Supplier Controls, Supplier Audits, etc.) and QC activities including PPAPs (e.g., PFDs, PFMEAs, Control Plans, FAIs, MSA/Gage R&Rs (Minitab), CAP Studies (Minitab) with a quality team of 40+, (4) reporting program metrics, KPIs, etc. to top management during management reviews, etc.

As a Quality Control Manager at CEI, makers of blanking/progressive stampings, CNC Swiss/Lathe/Wire/Mill machined components/assemblies for the Medical, Dental, Aerospace, Automotive, Firearms, Defense, Commercial, Energy, and Consumer Industries, I am responsible for (1) establishing/maintaining a QMS to the standards CEI claims compliance too, (2) serve as the QMR, (3) managing the day-to-day QA activities (e.g., NCRs, CAPAs, Complaint Investigation/Resolution, RMAs, Internal Auditing, Supplier Controls, Supplier Audits, etc.) and QC activities including PPAPs (e.g., PFDs, PFMEAs, Control Plans, FAIs, MSA/Gage R&Rs (Minitab), CAP Studies (Minitab) with a quality team of 5, (4) reporting program metrics, KPIs, etc. to top management during management reviews, etc.

As Director of Quality & Regulatory Affairs at KGI, makers of Customized Craniofacial and Skull Implants, I was responsible for (1) establishing/maintaining the QMS compliant to ISO 13485:2016, FDA 21 CFR Part 11, 801, 803, 806, 807, 820, 821 and ISO 14971:2012, (2) serve as the QMR and official correspondent to FDA, (3) managing QA/QC activities, (4) established/maintained design controls and performed V&V and PV&Q activities (wrote/executed plans, IQ, OQ, PQ protocols, summaries, etc.), (5) managed/maintained GUDID device database, (6) underwent 3 and prepared/submitted a Premarket 510(k) Notifications to FDA for the Customized Craniofacial and Skull Implants (K182711, FDA cleared on 21MAY2019).

As a Quality Engineer at CIVCO Medical Solutions, makers of Automated, High-Level Disinfection Preprocessors for Endovaginal, Endorectal, and TEE Ultrasound Probes, I was responsible for (1) co-authoring/implementing a QMS compliant to ISO 13485:2003, FDA 21 CFR Part 801, 803, 806, 807, and 820, ISO 14971:2012, MDD 93/42/EEC, CMDR SOR/98-282, and UL Laboratories, (2) managing/maintaining Calibration/PM Program (performing in-house calibration/PM activities), 5S Program, ESD Program, NCR Program, Supplier Controls Programs, Change Control Program, and Visual Metrics Program, and (3) performing/supporting Internal/External Audits, CAPA/Complaint Investigations, Inspection Acceptance (e.g., performing Incoming, In-process, and Final Inspections using C=0 Sampling Plan), supported Design & Manufacturing Engineering by performing design V&V and PV&Q activities (wrote/executed plans, IQ, OQ, PQ protocols, summaries, etc.), etc.

Makers of Noninvasive Sleep and Respiratory Devices and Accessories, (1) as Quality and Regulatory Affairs Specialist (Jan 2012/Jan 2015), I was responsible for establishing/ maintaining the QMS compliant to ISO 13485:2003, FDA 21 CFR Parts 801, 803, 806, 807, 820, ISO 14971:2012, MDD 93/42/EEC, CMDR SOR/98-282, and JPAL 169 as well as managing/maintaining Feedback, Complaints, Supplier Controls, internal and supplier audits, FAIs, investigated QNs, CAPAs, and SCARs, (2) as a Jr. Process Control Engineer (Jan 2009 - Jan 2012), I was responsible for managing production/quality processes, performing PV&Q activities (wrote/executed plans, IQ, OQ, PQ protocols, summaries), (3) as a Core Project Team Member/SAP Power User (Jun 2007/Jan 2015), I was responsible for software validation (e.g., enGage, GAGEtrak, various SAP modules), (4) as an ESD Co-Coordinator (Jan 2009/Jan 2015), I was responsible for co-designing/ managing the ESD Controls program activities, (5) as a Calibration/PM Coordinator (Jun 2005/Jan 2015), I was responsible for managing the Calibration/PM Program, and (6) as a Quality Supervisor (Mar 2004/Dec 2008), I was responsible for managing/performing FAIs, receiving, in-process, and final inspection.

Makers of Laparoscopic Instruments and Aerospace and Firearm Components, (1) as Quality Assurance Inspector, I was responsible for performing internal audits, FAI, receiving, in-process, and final inspection activities using C=0 Sampling Plan, investigated/processed NCRs and corrective actions, and maintained quality records, and (2) as a Calibration/PM Coordinator, I was responsible for managing the Calibration/PM Program, implementing GAGEtrak 5.0 Calibration Software, and (3) as an IT Support Specialist, I was responsible for maintaining the PCs, servers, backups, internet connectivity, and network integrity.

Makers of Automotive and Aerospace Fluidic Manifold Equipment, (1) as a machine operator (Jun 1994 - Jan 1996) and as Setup CNC Machinist (Jan 1996 - Jun 1997), I was responsible for operating manual Bridgeport’s, CNC Bridgeport’s, Surface Grinders, CNC machines with Fanuc controls and HAAS CNC 4th and 5th axis machines including deburring, inspection, with light CNC Programming and (2) as a Quality Control Inspector (Jun 1997 - Dec 2001), I was responsible for (A) managing/performing FAIs, receiving, in-process, and final inspection using various inspection equipment (e.g., OGP Smart Scope, Optical Comparators, micrometers, calipers, drop indicators, profilometers, air gages, surface plate layouts, etc.) and (B) performing IM&TE calibrations.

Makers of various equipment used in the medical industry such as Cartridge Housings, Jaws, hip joints, hardware, etc., (1) as a machine operator and as Setup CNC Machinist (April 1990 - July 1993), I was responsible for operating Tsugami Lightening Pallet Changer CNC machines and (2) as a Supervisor (July 1993 - June 1994), I was responsible for supervising the jaw line consisting of 4 operators/4 Tsugami Lightening CNC machines including tool changes and SPC inspection.