Kindly give reply to vino...@beyondtekit.com
This is my direct client opening for *Quality Engineer -2 - Memphis,
TN.This is a 6+
Months contract* position. *The client is looking for only LOCAL candidates.
*SUMMARY:* Responsible for concurrent quality engineering activities.
Participates in external and internal quality audits.
*ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties
may be assigned.*
· Participates in design control projects providing quality
· Serves as the independent reviewer on all assigned projects
ensuring that design history files comply with company policies and
· Reviews drawings to evaluate quality requirements including:
correct application of geometric dimensioning and tolerancing, proper use of
process and material specifications, and key characteristics for inspection
plans and gauging techniques.
· Recommends revisions to assure design requirements are specified
in the appropriate detail to provide a successful design transfer.
· Reviews and approves engineering change requests. Develops
inspection techniques that include identification of characteristics,
sampling plans, and gauging.
· Recommends gauging techniques including gauge work instructions –
assures gauges provide repeatable and reproducible results through the use
of statistical techniques.
· Uses quality tools to implement improvements including: process
flowcharting, pareto analysis, correlation and regression analysis,
significance tests, design of experiments, statistical process control,
gauge repeatability and reproducibility, and trend analysis techniques.
· Assists suppliers with the interpretation of quality requirements.
· Develops control plans that identify inspection characteristics,
gauging techniques, and sampling requirements.
· Works with suppliers to resolve conflicts and recommends revisions
· Assists the design control project team with the development of
essential design control deliverable including, but not limited to:
complaint analysis on similar products, risk analysis, failure mode and
effects analysis, essential requirements checklist, and design verification
· Assists with the development of protocols to ensure processes and
products are validated with the appropriate level of confidence.
· Assists in internal and external quality audits and inspections.
· Provides support to other Global Quality projects as needed.
*EDUCATION and/or EXPERIENCE: *
· *Requires GD&T/ Print reading and understanding, read and
understand design requirements, metrology experience, report technical
information (Must have)*
· Bachelor's degree in mechanical or biomedical engineering and 1-3
years related work experience
· CQE, CRE, etc. desired.
· Prior experience in the medical device industry preferred.
· Knowledge of CFR 21 Part 820 (QSR), ISO 13485, CMDCAS, MDD 93/42,
PAL, and other domestic and international regulations that may apply.
· Experience in mechanical evaluation or testing.
*OTHER SKILLS and ABILITIES: *
· Superior written and oral communication skills.
· CQE or other quality certification preferred.
· Overnight travel (up to 25%) may be required.
*Please complete the following skills-matrix and send back with your updated
Total IT Experience:
Total Quality Engineer exp:
Total exp of *GD&T/ Print reading and understanding, read and understand
design requirements:** please specify*
Total *metrology exp, report technical information: please specify*
Total exp in CQE, CRE, etc: please specify
Total exp in the medical device industry:
Total exp of CFR 21 Part 820 (QSR):
Total exp in ISO 13485, CMDCAS, MDD 93/42, PAL, and other domestic and
international regulations: please specify
Total exp in mechanical evaluation or testing:
Do you hold CQE certification or equivalent? Y/N
Are willing to Overnight travel (up to 25%)?Y/N
Whether is it C2C/1099/W2? If 1099, specify the corporate name:
Day Phone #:
Evening Phone #:
Cell Phone #:
Have you applied recently for this requirement earlier through any one else?
*Thanks & Regards,*
(* 714-857-2002 **x** **810*
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