Quality Engineer - Medical Device Start-up

Chicago Permanent USD85,000 - USD95,000 per year
  • Significant progression and growth opportunities
  • Capital backed Medical Device Start-up with great benefits

About Our Client

Our Client is a Medical Device Start-up specializing in creating a custom display solution for hospital monitoring use. They are looking to bring on a Quality Engineer to their growing team. The company prides itself on being cutting edge and providing a solution thats not only going to revolutionize the medical device industry but also save lives.

Job Description

  • Perform duties and responsibilities assigned by Director of Quality
  • Perform product, process, and change control risk mitigation actions, utilizing: Control Plans, pFMEAs, Flow Diagrams
  • Risk Assessment Audits, 5S Audits and ISO based Internal Audits
  • Work Instructions, Process Mapping and Checklists
  • Provide support for gage calibration program to meet ISO 9001 & ISO 13485 requirements
  • Create and implement new ISO 9001 and ISO 13485 procedures and work instructions
  • Provide quality engineering support to all departments.
  • Performs statistical analysis and write technical reports

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Bachelor's Degree from an accredited college or university
  • Experience working in an environment certified to ISO 13485:2016 and CGMP Good Manufacturing Practices and the FDA
  • Experience with Lean / Six Sigma Problem Solving tools
  • Ability to work with mathematical concepts such as probability and statistical analysis
  • Good understanding of SPC and Gage R&R including conducting studies and reporting results

What's on Offer

  • Competitive base salary, dependent on experience, between $85,000 and $95,000
  • Medical, dental and vision insurance through BCBS
  • 15 days of Vacation
  • 5 Sick Days + 2 Personal Days
  • 10 Paid Holidays
  • 3% 401k Match
  • Tuition reimbursement
Megan Mcdonald
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Job summary

Engineering & Manufacturing
Sub Sector
Quality, Technical
Industrial / Manufacturing
Contract Type
Consultant name
Megan Mcdonald
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