Quality Systems Specialist

Industry : Medical Device


Role Summary:

The Quality Systems Specialist will lead a project to streamline quality system procedures under the supervision of the Director of Quality Assurance. This role is responsible for assessing the current complex structure and work with sub-system owners to simplify, rationalize and streamline the current set of procedures with a goal to reduce the overall number of procedures by at least 30%.

The candidate needs to have a quality compliance background, preferably with Documentation Control and Change Management experience and be able to work well with all areas and levels of the organization.


Job Responsibilities:

  • Review and assess current procedure content and rationalize and simplify procedure content
  • Draft updated SOPs.
  • Coordinate with sub-system owners and the wider organization
  • Implement rationalized procedures via a newly introduced Change Management System
  • Ensure project implementation to meet project timelines.


Educational Requirements:

Bachelor’s degree or equivalent in Chemistry or a related science is desirable.


Required Job Experience/Skills:

  • 3+ years of Quality Assurance Experience or equivalent.
  • Excellent Technical Writing ability.
  • Knowledge of GMP and ISO 13485 requirements.
  • Experience of Doc Control and Change Management systems (with experience of Windchill Change Management module an advantage).
  • Team-work oriented.
  • Project management ability.
  • Sense of organization and priorities.
  • Strong communication (oral and written); Ability to multi-task.
  • Attention to detail.


Contract Duration:  6 Months Project

Location:  Midwest Region

To apply for this job email your details to enquiries@qaresources.com.