Quality Engineer/Analyst in Minnetonka, MN at DISYS

Date Posted: 7/27/2018

Job Snapshot

Job Description


Job Title: Quality Engineer/Analyst


Location: Minnetonka, MN


Duration: 6 months  


 


Description:


 



•       The purpose of this position is to initiate medical device quality assurance activities.



•       These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.


 


Essential Duties and Responsibilities:



•       Develop incoming inspection processes and document incoming inspection activities.



•       Provide in-process QA support to include inspection and document review. Complete final acceptance activities.



•       Manage the sterilization process, including validations and product sterile loads.



•       Track nonconforming material and lead Material Review Board (MRB) efforts.



•       Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned product.



•       Manage corrective action and quality improvement activities.



•       Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing.



•       Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.


 


 If interested kindly reach me out at the undersigned.



Warm Regards,


Vignesh


IT Recruiter


Digital Intelligence Systems, LLC (DISYS)


Phone: (972) 776 6773 | www.disys.com


Email: Vignesh.rajavel@disys.com

Job Requirements


Job Title: Quality Engineer/Analyst


Location: Minnetonka, MN


Duration: 6 months  


 


Description:


 



•       The purpose of this position is to initiate medical device quality assurance activities.



•       These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.


 


Essential Duties and Responsibilities:



•       Develop incoming inspection processes and document incoming inspection activities.



•       Provide in-process QA support to include inspection and document review. Complete final acceptance activities.



•       Manage the sterilization process, including validations and product sterile loads.



•       Track nonconforming material and lead Material Review Board (MRB) efforts.



•       Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned product.



•       Manage corrective action and quality improvement activities.



•       Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing.



•       Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.


 


If interested kindly reach me out at the undersigned



Warm Regards,


Vignesh


IT Recruiter


Digital Intelligence Systems, LLC (DISYS)


Phone: (972) 776 6773 | www.disys.com


Email: Vignesh.rajavel@disys.com

Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.