Urgent requirement for Quality Engineer Location: Plymouth, MN

*Looking exp. on Medical Domain* *Position: **Quality Engineer* *Location: * *Plymouth, MN* *Duration: 12+ months* *Job Title* Quality Engineer *Relevant Experience * *(in Yrs)* 5-6 Year in Medical Industry or regulated industry *Technical/Functional Skills* · Quality Engineering working knowledge and Quality Management Experience · working knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements and the ability...

*Looking exp. on Medical Domain*

*Position: **Quality Engineer*

*Location: * *Plymouth, MN*

*Duration: 12+ months*

*Job Title*

Quality Engineer

*Relevant Experience *
*(in Yrs)*

5-6 Year in Medical Industry or regulated industry

*Technical/Functional Skills*

· Quality Engineering working knowledge and Quality Management Experience

· working knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements and the ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across product lines

· Strong working knowledge of ISO 14971 Risk Management Process (System Risk Analysis, DFMEA/FMEA and other Risk Management tools) 

· Good experience in CAPA
· Working knowledge of Microsoft office products (MS Word, Excel) and Statistical Analysis Software tools
· Validation activities, writing protocols and reports. Validation execution
· Engineering change order
· Development of a Standard Procedure (SP), related Work Instructions (WI), Forms, Checklists for design verification and validation activities

*Experience Required*

5-6 Medical Industry or regulated industry experience

*Roles & Responsibilities*

· Support non-conformance activities for their resolution
· Support CAPA activities for their closure
· Work and review incoming inspection report
· Support protocol and Technical reports
· Quality reviews for documentation
· Audit Preparation and Support
· Interact with stakeholders for review and alignment
· Project Management support as needed
· support and provide guidance on Validations
· Creation of Quality Plans
· Execution of Quality Plan Deliverables

*Education*

Mechanical/Bio-medical Engineering
Preferred Education: Master’s Degree

*Duration of assignment *(in Months) 12 months







*Thanks & Regards*

*Atul Singh*

*Insigma Inc | 43490 Yukon Drive, Suite 102, Ashburn, Virginia 20147*

*Phone: **703-344-9674 ext 126*

*Email: **atul.singh@us.insigmainc.com ** I Fax: 888.428.2340*

*Hangout: atul.ustrg@gmail.com *