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Quality Specialist | Medical Device

Company

Michael Page
Address Chicago, IL, United States
Employment type FULL_TIME
Salary
Category Appliances, Electrical, and Electronics Manufacturing,Industrial Machinery Manufacturing,Manufacturing
Expires 2023-08-10
Posted at 10 months ago
Job Description
  • Great Benefits Including Unlimited PTO|Investments and Projects With Michael J Fox & Gate Foundation
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 Specialist to their growing team. The company prides itself on being cutting edge and providing a solution that's not only going to revolutionize the medical device industry but also save lives.

  • Provide support for gage calibration program to meet ISO 9001 & ISO 13485 requirements
  • Perform product, process, and change control risk mitigation actions, utilizing: Control Plans, pFMEAs, Flow Diagrams
  • Create and implement new ISO 9001 and ISO 13485 procedures and work instructions
  • Work Instructions, Process Mapping and Checklists
  • Risk Assessment Audits, 5S Audits and ISO based Internal Audits
  • Performs statistical analysis and write technical reports
  • Provide quality engineering support to all departments.
  • Perform duties and responsibilities assigned by Director of Quality
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
  • Experience with Lean / Six Sigma Problem Solving tools
  • Good understanding of SPC and Gage R&R including conducting studies and reporting results
  • IQOQPQ experience
  • Bachelor's Degree in Engineering
  • ISO 14971
  • CFR Part 820
  • Ability to work with mathematical concepts such as probability and statistical analysis
  • Experience working in an environment certified to ISO 13485:2016 and CGMP Good Manufacturing Practices and the FDA
What's on Offer
  • Medical, dental and vision insurance through BCBS
  • 3% 401k Match
  • Competitive base salary, dependent on experience, between $100,000 to $120,000
  • Unlimited PTO
  • Tuition reimbursement
  • 10 Paid Holidays
Contact: Jenna Algozine
Quote job ref: JN-072023-6112955