Quality Engineer /Manager

San Jose, Ca. ***** • 408-***-**** • fqrm0p@r.postjobfree.com

Chris Scott

Objective

Seeking a position where I can apply my technical and personal skills to significantly improve processes and systems following quality standards.

Experience

2009-2009 Cholestech Corporation Hayward, Ca.

Quality Control Inspector II

 Perform IQC inspection of materials, components and finished devices

 Initiate NCMRs for non-conforming materials and devices and obtain MRB approvals

 First Article Inspection

 Routinely perform basic laboratory tasks and provide QC support, ,lab cleaning, along with special assignments

 Experience working within FDA’s cGMP/QSRs, ISO 9000

 Knowledge and experience with inspection tools: Calipers, Micrometers, Microscopes, Video scopes, etc

 Set-up YSI machine for phlebotomy donor testing

 Knowledge of ANSI/ASQC sampling standards

 Work with supplier quality engineers to determine critical material requirements

2004-2009 HemoSense, Inc. San Jose, Ca.

Quality Control Inspector II

 Performed dimensional and electrical inspection of raw materials/components related to strip manufacturing

 Review and trend test data to ensure specifications are being met

 Inspect all incoming product using AQL sampling techniques

 Initiated Non-Conforming material reports for discrepancies observed during inspection, and help lead MRB meetings

 Create and update Standard Operating Procedures, Work Instructions and Manufacturing Procedures

 Coordinate and maintain equipment for calibration

 Work with engineering and R&D on protocols and validations

 Conduct line clearances and audits on daily basis

 Inspection of all in-house kits being built

 Maintain and complete batch records to ensure product quality

 Implemented requirements for daily in-house monitoring and recording data of controlled room temperature, air pressure differential and room humidity

2003-2004 HemoSense, Inc. San Jose, Ca.

Manufacturing Technician

 Perform all functions related to diagnostic strip manufacturing (formulation, dispense/drying, lamination, inspection, card slice, pouch, product test, etc)

 Set- up Micro Dispensing System with weight measurements and qualifications

 Knowledge of GMP’s, ISO guidelines, SOP’s and quality system procedures directly related to the manufacturing process

 Execute manufacturing of meters (inspection, testing and product kitting)

 Setup operation of automated equipment

 Assist engineering (protocols, studies, validations and qualifications)

2003-2003 Palo Alto Medical Foundation Palo Alto, Ca.

Material Handler/Kit Assembly

 Deliver medical supplies to main hospital.

 Pull and pack kits for shipment.

 Deliver instruments to departments

 Maintain inventory records and reconcile movement of material

 Perform the physical and administrative tasks involved in receiving and distribution of inventory and supplies

 Creation of carriers documents domestic and international, arrange for pick up of international palletized shipments

 Pull, pack and ship domestic and international outbound shipments in compliances with internal and external regulations

Education

2007-Present San Jose City College (AA in progress) San Jose, Ca.

SKILLS:

 Software applications: Microsoft office, Word, Excel, outlook, Access, PowerPoint, smart solve

 Manufacturing Lead

 Clean Room/Microscope

 Specs Reading/Blueprint

 Training Skills/Final Inspection

 Excellent Communication Skills

 MicroVu/CMM

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