Engineer Quality
Job Title : Quality Engineer
Duration : 03 Months
Location : Scarborough ME
Description :
Thepurpose of this position is to initiate medical device qualityassurance activities. These activities must be in accordance withFDA Quality System Regulation ISO13485 and other internationalstandards.
This position will also support device complaintinvestigation and failure analysis as required. Essential Dutiesand Responsibilities : Develop incoming inspection processes anddocument incoming inspection activities.
Provide inprocess QAsupport to include inspection and document review. Complete finalacceptance activities. Manage the sterilization process includingvalidations and product sterile loads.
Track nonconforming materialand lead Material Review Board (MRB) efforts. Interface and takelead QA role in interactions with suppliers contractors andconsultants that supply components subassemblies and contractprocessing.
Lead complaint investigations on returned product.Manage corrective action and quality improvement activities. Manageaspects of internal quality system relating to receiving inspectioncalibration MRB etc.
Assist in the performance of quality systeminternal auditing. Support quarterly management review meetings.Establish monitor and evaluate quality system metrics.
Additional Details
- Start Time (AM / PM) : 5 : 30am 2pm
- End Time (AM / PM) : MondayFriday
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