Hi,

Hope you are doing well, My Name is Sam and I am from Enterprise solution,
I have a good opportunity for you  Please go through the requirement and
send me your updated resume and below mentions Details at
*sham...@enterprisesolutioninc.com
<sham...@enterprisesolutioninc.com>*





*Job Title:* ONSITE QA ENGINEER - ISO 13485 ad ISO 14971 experience needed

*Location:* Salt Lake City, UTAH



*Overview:*

ONSITE QA ENGINEER

Work on Customer (field) Complaints, Process NCRs and CAPAs
Medical operations design controls (test protocols and reports, validation
plans, engineering change notices, CAPA investigations, non-conformance
reports, etc.)
Perform Trend analysis and initiate CAPAs (as required)
Supports investigation and resolution of NCRs and CAPAs
Root cause analysis using problem solving techniques (such as 5 why
analysis, Fish Bone Diagram)
Review Investigations for completeness, CAPA closure and monitor for
implementation
Statistical Process Control
Process Validation & MSA
6 sigma, process improvement, yield improvement, scrap reduction
Fixture validation (IQ / OQ / PQ/ PFMEA, etc.)
Product failure investigation (plastic injection molded parts, bearing
failure, etc.)
3rd party tool and process validation (new multiple cavity plastic
injection molded parts, replacement epoxy qualification, etc.)



*Primary Skills:*

5-6 YEAR EXPERIENCE OF WORKING IN MEDICAL DEVICE INDUSTRY WITH EXPOSURE TO
PROCESS QUALITY AND COMPLIANCE REQUIREMENTS
KNOWLEDGE OF ISO 13485 AND IN FDA 21 CFR PART 820 REQUIREMENTS
KNOWLEDGE OF ISO 14791 APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
SIX SIGMA GREEN OR BLACK BELT



*Secondary Skills:*



*Educational Qualifications*

B.E/B.TECH (MECHANICAL)



*Personal Details of the consultant*



Full Name as per Records



Best Number to reach



Secondary Number



Best Time to reach



Email Id



Rate/hr or Salary per annum



Work Authorization



Current Location



Willing to relocate



Current Project Status



Availability



Notice Period required to start from the date of confirmation



Any special Remarks or notes









Sam

Enterprise Solutions, Inc.

Email : sham...@enterprisesolutioninc.com

Contact-Desk-4086933156

Cell-3313052509

www.enterprisesolutioninc.com

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