Specialist, Quality Systems

Are you looking to maximize your knowledge and use it for the greater good? To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas?

A Medical Device company in the Chicagoland area is looking for a Quality Assurance Specialist to perform activities used to maintain quality processes required for Medical Device manufacturers and initial distributors including compliance with FDA, GMP, ISO, OSHA and similar regulatory quality requirements.

Among others, this Quality Assurance Specialist would be responsible for:

  • Supporting the development and maintenance of key aspects in SAI Quality Systems, to assure compliance with FDA Quality Systems Regulations and ISO requirements.
  • Day to day management and coordination of CAPA actions and CAPA coordination throughout the company's quality system in response to pertinent observations from the audit program.
  • Performing and assisting with internal audits and supplier audits as required to support the SAI Quality System.
  • Assisting in the gathering, trending and reporting of metrics that effectively measure and communicate quality performance.
  • Working closely with on-site Quality Assurance team and cross-functionally in understanding, identifying gaps and proposing changes to processes that affect quality systems compliance
  • Supporting the company's deployment of Quality System processes and procedures and promotes ongoing education of the company's knowledge of the Quality System and regulatory requirements.

The most ideal candidate for this Quality Assurance Specialist role will have the following qualifications:

  • Bachelor's degree preferred.
  • 5-7 years total career experience.
  • Knowledge of cGMP (FDA QSR) and ISO regulations.
  • Proficient in English.
  • Microsoft Word, Outlook, Excel, PowerPoint, and Access skills.
  • Strong communication and interpersonal skills.
  • Ability to obtain cooperation, develop a consensus and lead or influence cross-functional teams.
  • Strong analytical skills and problem solving ability

This opportunity gives a candidate the ability to be in a strategic role, play a key role within the executive team and be a part of an organisation that is creating an innovative and cutting-edge product line.

If you would be interested in exploring this exciting opportunity, please apply directly with an attached resume and the best time to reach you.

Sthree US is acting as an Employment Agency in relation to this vacancy.