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Immediate Job Opening - Quality Engineer (Medical Device) - MN

In Minnesota / United States

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Immediate Job Opening - Quality Engineer (Medical Device) - MN   

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JOB TITLE:
Immediate Job Opening - Quality Engineer (Medical Device) - MN
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Saint Paul Minnesota / United States

JOB DESCRIPTION :
Hi, Please find the below job description and if you are interested, please send me your updated resume to saichandra@intellectt.com. Thank You.
Role: Quality Engineer (With Risk Management)
Location: St. Paul, MN
Duration: 12+ Months on W2
Job Description:
  • Create, review and maintain risk management files.
  • Lead cross functional teams in the creation and maintenance of risk analysis documents.
  • Ensure that product development projects and changes to existing products and processes are incorporated into the risk management process.
  • Support the continuous improvement to the Quality Management System, with a specialty focus on risk management and associated processes.
  • Act as the lead team member in establishing, communicating and mitigating risks.
  • Review design history files and technical files for conformance to applicable requirements.
  • Experience supporting ISO 13485 inspections and FDA inspections.
  • Experience in a multi-site development environment.
  • Experience in compliance management within a rapid-growth, dynamic organization.
  • Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.
  • Provides leadership in the understanding of FDA and applicable non-US regulations pertaining to medical or pharmaceutical manufacturing, including hardware, software, and bioassay systems.
Educational Qualification:
  • Bachelors' degree (B.S.) in a Science related field, or equivalent combination of education and experience
  • 1-3 Years related experience and/or training in a Quality and/or Development Position.
  • Significant experience in risk management throughout the product lifecycle, including a strong working knowledge of ISO 1497
  • Communicates effectively at all levels within Quality as well as cross-functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing

Position Details

Apr 11, 2021
S16174660634232814
Minnesota / United States
Saint Paul
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Immediate Job Opening - Quality Engineer (Medical Device) - MN    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Hi, Please find the below job description and if you are interested, please send me your updated resume to saichandra@intellectt.com. Thank You.
Role: Quality Engineer (With Risk Management)
Location: St. Paul, MN
Duration: 12+ Months on W2
Job Description:
  • Create, review and maintain risk management files.
  • Lead cross functional teams in the creation and maintenance of risk analysis documents.
  • Ensure that product development projects and changes to existing products and processes are incorporated into the risk management process.
  • Support the continuous improvement to the Quality Management System, with a specialty focus on risk management and associated processes.
  • Act as the lead team member in establishing, communicating and mitigating risks.
  • Review design history files and technical files for conformance to applicable requirements.
  • Experience supporting ISO 13485 inspections and FDA inspections.
  • Experience in a multi-site development environment.
  • Experience in compliance management within a rapid-growth, dynamic organization.
  • Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.
  • Provides leadership in the understanding of FDA and applicable non-US regulations pertaining to medical or pharmaceutical manufacturing, including hardware, software, and bioassay systems.
Educational Qualification:
  • Bachelors' degree (B.S.) in a Science related field, or equivalent combination of education and experience
  • 1-3 Years related experience and/or training in a Quality and/or Development Position.
  • Significant experience in risk management throughout the product lifecycle, including a strong working knowledge of ISO 1497
  • Communicates effectively at all levels within Quality as well as cross-functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing