Medical Device SR. Quality Engineer

Fort Wayne, IN

Industry: Medical Device Job Number: 146751

 

Medical Device Sr. Quality Engineer

Environment:

Our client is a leading medical device manufacturer of Class II devices. In need of Sr. Quality Engineers from the GMP/Manufacturing side of things to come in and help with a  Design Transfer.  Ideally the consultant will have a medical device background and have done a tech transfer or  design transfer  in the past.

Roles/Responsibilities:

Looking for a Sr. Quality Engineer with Design Transfer experience to provide support and expertise. The consultant will be responsible for reviewing and updating documents. This person will be working closely with Design and Development with new Product Lines. Must have experience reviewing prints, inspection data, and remediation of design controls. The parameters and  templates have been made they need someone who can conduct Capability Analysis and Gage R&R.  This person will also be helping with Validation’ s, equipment and Test method. If this person has experience training operators that would be a big plus.

This QE will need to work in a team but as an independent. Need to have 10+ years of experience in the Medical Device industry and be up to date with ISO 13485 2016.

Required:

-    10+ yrs experience in Medical Device

-    7-10+ yrs QE 

-     Design Control

-     Capability Studies

-     Gage R&R

-    Orthopedics

Job Type: Contract

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