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Senior Quality Engineer - Medical Device Manufacturing

Chicago, Illinois
Job Type
12 Sep 2022
* Perform duties and responsibilities assigned by Director of Quality.

* Perform product, process, and change control risk mitigation actions, utilizing:

* Control Plans,

* Potential Failure Mode and Effects Analysis,

* Process Flow Diagrams,

* Risk Assessment Audits, 5S Audits and ISO based Internal Audits,

* Work Instructions, Process Mapping and Checklists.

* Provide support for gauge 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.

* Ensures nonconforming products are processed per standard operating procedure.

* Identify and develop solutions to recurring issues.

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.

* 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.

* Ability to write reports, business correspondence, and procedure manuals.

* Experience with process validation is preferred. Experience with CNC machining is a plus.

* Good organizational skills.

* Good communications skills.

Our Clients is an industrial Manufacturer in the northwest suburbs of Chicago. They provide high quality precision machined components to industries like medical device, aerospace, technology, and military. They are looking to expand their quality team to help facilitate their growth.

* 3 weeks of vacation, 2 personal days, 9 paid holidays, 5 sick days

* Medical, BCBS of Illinois Dental, Guardian Vision is IMED

* Company paid life insurance

* Identify theft life insurance

* 401K 4% match after 1 year

*Apply now and your resume will be considered within 24 hours!*
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  • Job Reference: 710312433-2
  • Date Posted: 12 September 2022
  • Recruiter: Michael Page
  • Location: Chicago, Illinois
  • Salary: On Application
  • Sector: Engineering
  • Job Type: Permanent