Post-Market Quality Engineer x3

Philadelphia, PA

Industry: Medical Device Job Number: 134389

Post-Market Quality Engineer x3

Summary: Our client is a large medical device manufacturer that develops a number of Class III Medical Devices. They are currently in need of a Post-Market Quality Engineer to support a large global project.

Background: Our client is currently in need of a Post-Market Surveillance Quality Engineer to provide expertise in Statistical Data Analysis, Trending Analysis to  analyze Post-Market  data in an effort understand Root Cause issues. This individual should come from an Engineering background and must have a strong experience in Medical Device Product Quality, Investigations- Product, Complaint & CAPA,  Post-Market Data Analysis, Risk Management, Risk Benefit/Analysis, Statistical Data Analysis, Trending Analysis, and should be a creative problem solver. 

Day-to-Day Responsibilities:
  • Collection, analysis, and evaluation of post-market, product safety and performance data, with the intent to detect safety signals and determine whether these signals are issues that warrant further action.
  • Conduct trend analyses, signal detection and product investigations with the focus on early warning of patient safety as well as product quality issues.
  • Review & understand current risk profile of our products while assessing the overall risk/benefit of the product.
  • Review and update risk management files for completeness and accuracy.
  • Lead or support CAPA activities  to address any product issues and facilitate field actions, as needed and may also support other quality system activities such as Complaint Investigations, Internal Audits, and third party inspections.

Required:
  • Medical Device 
  • Post-Market Quality
  • Product Quality
  • Investigations (Product, Complaint & CAPA)
  • Risk Management
  • Risk Benefit Analysis
  • Engineering Background
  • Statistical & Trending Analysis
  • Complaint & MDR Data Analysis 

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