Quality & Regulatory Affairs Manager

Chicago, Illinois, United States

Posted on 12/18/2019

Position Details




Healthcare / Medical Devices

Job Level:

Standard Management (Manager/Supervisor of Staff)


Bachelor's Degree

Reference ID:


Don't miss this Career Opportunity!


Leading provider of high precision manufacturing products for the Medical Device Industry with multiple facilities both Global and Stateside. This growing world class company is a leader in manufacturing Medical Device and Solutions.


Quality & Regulatory Affairs Manager - Medical Device


MRINetwork is seeking a Quality & Regulatory Affairs Manager


Position Summary of Skills:

  • Strong leadership and management skills
  • Familiarity with Regulatory Standards, such as: cGMP, FDA, QSR, ISO13485, and Medical Device Directives
  • Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison)
  • Computer literate (i.e. date-base development, statistical software and analysis, word processing for report generation, etc.)
  • Strong negotiation and problem-solving skills
  • Excellent communication (verbal and written) skills; ability to lead teams and communicate effectively with multiple levels of the organization
  • Supplier auditing skills (i.e. ASQ-CQA, internal/external courses, seminars)
  • Able to understand blue prints, tolerance analysis, inspection methods, and related knowledge
  • Strong reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems and conflicts


Education and Experience:

  • B.S. Degree in related discipline or equivalent experience preferred
  • Minimum of 3 years as a Quality Engineer with Medical Device experience in manufacturing operations, with process qualification experience preferred
  • ASQ Certification is a plus


The company offers a very attractive benefits package and compensation! Relocation provided!


Company is interviewing today! Please contact me now for more details!


Send your resume to kelliott@sncompanies.com or call Kevin Elliott at 817-857-7713 to learn more.