Management Inspector
Resume:
Philip Dominguez
*****@*****.***
Summary:
Over 20 Years of Experience as a IQA Inspector, Lead Quality Control, Clean Room Inspector and as a Incoming/ In Process/ Receiving Inspector
Hands-on experience in Quality Systems regulations
Possess knowledge in Current Good Manufacturing Practices (CGMP)
Hands-on experience in Materials Specifications Procedures (MSP), Manufacturing Process Instructions (MPI) and Standard Operation Procedures (SOP)
Experience in working with Micro Vu,CMM,, Calipers, Micrometers, ROI,Instron, Height Gauges, Pin Gauges, CIRRIS Tester, Thread Checkers, Smart Scope, ISO Standards/IPCA 610/ISO 9000-9001,13485 CFR 820, SAP, AGILE, JD Edwards, PC-DMIS Documentation Review
Knowledge of Current Good Manufacturing Practices(cGMP) and applicable Quality System Requirements.
Ability to perform activities to support product development, administration, manufacturing and other company activities or other duties as assigned.
High attention to detail, very diligent and passionate to do the right thing.
Self-driven, quick learner, with the ability to take initiative and multi-task under tight deadlines with ample autonomy.
Ability to work independently, to analyze and problem solve issues that impact quality.
Exceptional organization and time-management skills.
Excellent English written and verbal communication skills.
Education: High School diploma / Certification from Hexagon metrology
Professional Experience:
ZenFlow South San Francisco, CA Dec 2017- Present
Lead Inspector
FAI’s/Incoming Inspection,Micro VU, In Process, Final Inspection
Good knowledge of ISO 13485,9000 and 9001, CFR 820
Functional testing of balloons, graspers,handles,Gears
Tubing, test fixtures, wire, cable, molded parts, PCB/PCBA boards, Machine Parts
Dextera Surgical Redwood City, CA Oct 2016- Jan 2018 Incoming Inspector
Running CMM
Programs,Vision Systems,Smartscope,Microscope
Inspection of wire, tubing, handles, molded parts,Machined Parts
Non-Conformance Reports (NCMR, NCR)
Interaction with Supervisors and Management on production needs
Pro-active in problem solving as well as multi-tasking
Documentation Review /label /IFU’s
Good knowledge of GMP’s and ISO 9000/ISO 9001 13485 CFR 820
Finesse Santa Clara, CA Jan 2015 – July 2017
QC Inspector
Incoming; In-Process and Final Inspection
FAI Inspection, In Process, Point to Point Wire Check,tanks inspection, rocker table assemblies,Incoming Inspection, Motors, Pumps, Fuses, Cables/Wires
Interaction with Supervisors and Management on production needs
Pro-active in problem solving as well as multi-tasking
Non-Conformance Reports (NCMR, NCR)
Documentation Review
Good knowledge of GMP’s and ISO 9000/ISO 9001 13485 CFR 820
Creganna Medical, Campbell, CA Nov 2014 – Dec 2015
QC Inspector/CER Lead Inspector
Inspections:Catheters,Stents,Hypo-Tubes,Tubing,Labels,IFU’s, Molded/Machined Parts,cables,wires
Documentation Review
Good knowledge of cGMP’s, FDA and ISO 9000/ISO 9001 13485 CFR 820
Pre & Post Sterilization/Assembly
Functional Testing of incoming cable/wire/tubing
Non-Conformance Reports (NCMR)
Sonitus Medical, San Mateo, CA Jan ‘2014-Nov ‘2014
IQA Inspector
Good knowledge of cGMP’s, FDA and ISO 9000/ISO 9001 13485 CFR 820
Receipt inspection:Molded Parts PCB’s/PCBA’s,IFU’,Labels,Packaging
First Article and Pre & Post Sterilization/Assembly
Functional Testing of incoming cable/wire/tubing
Non-Conformance Reports (NCMR)
Documentation Review
Interaction with Supervisors and Management on production needs
Pro-active in problem solving as well as multi-tasking
Interaction with Supervisors and Management on production needs
Pro-active in problem solving as well as multi-tasking
Contact this candidate