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Sr. Quality Engineer

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Location
Irvine, CA
Salary
$95,000 - $95,000
Job Type
Direct Hire
Date
Oct 09, 2017
Job ID
2513511
About the Career Opportunity:  A client of ours a Medical Device established company  is looking for a focused Sr. Quality Engineer in the Medical Device Industry.This is an opportunity to have a big impact into helping people.  If you are looking for the next step in your career don’t hesitate.

PRIMARY RESPONSIBILITIES
1 Ensure compliance with all medical device regulatory requirements include but not limited to FDA guidelines, ISO standards and MDD 93/42/EEC.
2 Provide expertise in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques.
3 Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives.
4 Maintain and update knowledge in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques.
5 Participate in failure investigations for product failures encountered during the New Product Development as well as after product launched.
6 Collaborate with suppliers on quality issues.
7 Trend and report quality data to management as needed.
8 Maintain and facilitate the Engineering Document Change request (ECR) process, providing general word processing and formatting assistance, coordinating the review/approval process, tracking and maintaining applicable logs, and sending out training notifications upon document approval.
9 Interface with employees to answer questions regarding controlled documents and the DCR/ECR/NCR processes.
10 Monitor progress of documents under ECR/NCR and follow up with appropriate staff to ensure timely completion.
11 Prepare product related Quality Metrics and reports.
12 Perform sample document audit in related document control as needed.
Maintain electronic and hardcopy history files of controlled documents, including those from external parties, and ensure accurate and reliable filing systems. 

 

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