Quality & Regulatory Affairs Manager

Chicago, Illinois, United States

Posted on 12/18/2019


Position Details

Type:

Permanent

Industry:

Healthcare / Medical Devices

Job Level:

Standard Management (Manager/Supervisor of Staff)

Education:

Bachelor's Degree

Reference ID:

EB-2121816267

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.