Quality Specialist Ii

Thermo Fisher Scientific

Detroit, Michigan, USA
Iso 13485:2016 compliance
Internal audit program management
Change management oversight
Drive compliance and continual improvement of key QMS elements including audit program, change management, customer notifications, quality systems compliance, document control, and training

Job Summary

  • Drive compliance and continual improvement of key QMS elements including audit program, change management, customer notifications, quality systems compliance, document control, and training.
  • Maintain the site’s Quality Systems’ compliance to ISO 13485:2016 standards and regulatory requirements and policies as applicable.
  • Support production partners as needed, to ensure on-time delivery to customers.

Matching Summary

Drive compliance and continual improvement of key QMS elements including audit program, change management, customer notifications, quality systems compliance, document control, and training.

Skills & Requirements

Must-have

  • ISO 13485:2016 compliance
  • Internal audit program management
  • Change management oversight
  • Document control program
  • Customer compliance inquiries
  • Root cause analysis
  • Corrective action implementation

Nice-to-have

  • Life sciences industry familiarity
  • Team and matrixed environment
  • Driven and resourceful approach
  • Prioritization and time management

Key Requirements

  • Bachelor's Degree in Science
  • Minimum 2 years QA experience
  • ISO 13485 environment experience
  • Auditing experience

Work Rights

Not specified

Tailored Resume

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