Urgent Requirement :: Quality Engineer (Medical Devices) :: Warsaw, IN 46580

[Manish Gupta]

Hi,

 

Hope you are doing great! Please find the requirement below , If you find yourself comfortable with the requirement please reply back with your updated resume and I will get back to you or I would really appreciate if you can give me a call back at my contact number 609-853-0818 Ext.2177 raj...@nityo.com.

 

Role : Quality Engineer (Medical Devices)

Work Location : Warsaw, IN 46580

Duration: 12 months

 

Technical/Functional Skills

·         Knowledge of basic quality tools, risk analysis.

·         Ability to read and understand engineering drawings

·         Knowledge of Quality System requirements, ISO and FDA requirements (preferred)

·         Ability to effectively work within a team to expedite completion of critical project tasks with other functional groups

·         Experience with Statistical Process Control and inspection techniques

 

Roles and Responsibility:

·         Analyze/review effectiveness of preventive and corrective actions.  Review root cause investigation according to an established process.

·         Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality

·         Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.

·         Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

·         Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs

·         Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements

·         Interface with Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes.

·         Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line.

·         Identify, analyze, and manage risk through product life cycle with use of FMEA and other risk management tools.

 

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Thanks & Regards

Rajat Baliyan
(Sr. Technical Recruiter)
Phone : 609-853-0818 X 2177
Fax : 609 799 5746 
Email: raj...@nityo.com
www.nityo.com