Quality Engineer - Medical Devices - Lincolnshire

Lincolnshire Permanent USD70,000 - USD90,000
  • Brand new state of the art facility
  • Significant growth opportunities

About Our Client

Our client is a private equity backed manufacturer located in the Wheeling area. This is a new role for their business and will report to their Director of Quality. They focus on the medical device industry and have a robust QMS built out. This client puts an emphasis on growth and development for their employees and promote heavily from within.

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
  • Ability to read and understand blueprints, including GD&T
  • Experience working in an environment certified to ISO 9001:2015, ISO 13485:2016 and CGMP Good Manufacturing Practices
  • 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 $75,000 and $90,000
  • 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
Evan Gilbert
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Job summary

Engineering & Manufacturing
Sub Sector
Quality, Technical
Healthcare / Pharmaceutical
Contract Type
Consultant name
Evan Gilbert
Job Reference