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Quality System Specialist

3 months ago

Brooklyn Center, United States Redbock - an NES Fircroft company Full time

Quality Systems Specialist (Through June 2025 // Brooklyn Center, MN):

*W2 ONLY*- Not Available for OPT/STEM

Alternative Title: QMS Specialist

Hybrid work setting (most activities can be done remotely but expect 2 days on site per week)


HM's Top Needs:

  1. Regulated Industry Experience (preferably med device or pharma)
  2. Experience managing Quality Management System documents/systems and Learning Mgmt Systems (Training)
  3. Ability to manage multiple projects and competing priorities


Description:

This role is for a QMS Specialist. This person will be helping out to cover many aspects of the QMS while other team members are helping with a document repository transition. Helping with QMS documentation, LMS (training) systems and assigning training, document control, etc. This role supports a large manufacturing site. A high level of customer service and attention to detail is necessary.


Education Required: Bachelor’s Degree

Years’ Experience Required: 3-5 years


Duties:

  • Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Coordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.


Required Knowledge and Experience:

  • Experience with execution of CAPAs
  • Previous experience working with Learning Management Systems
  • Previous experience with management of training activities
  • Previous experience working with an eQMS


Preferred Experience:

  • Previous experience with QMS Simplification