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Management Inspector

Location:
San Carlos, California, United States
Posted:
May 28, 2018

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Resume:

Philip Dominguez

ac5m99@r.postjobfree.com

650-***-****

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