Icon hamburger
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Mvt6g86g8n6k0ywr1bq

Specialist, Quality Systems

Real Staffing Chicago Full-Time
$70,000.00 - $85,000.00 / year
Apply Now

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.

 

Skills required

Good Manufacturing Practices
Operations
Manufacturing
Product Quality Assurance
Technical Services
Raw Materials
Apply to this job.
Think you're the perfect candidate?
Apply Now

Job ID: RE-33182228

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.



Real is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services. We are one of the world’s most extensive pharma, biotech and medical devices recruiters and have one of the largest networks of specialist recruiters globally.

Our premise is a simple one: by recognizing talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time.

View the full profile