Principle Quality Systems Specialist

Are you an experienced Principle Quality Systems Specialist? Looking for an exciting new challenge within the ever-growing Medical Device industry? Look no further! My client, a leading medical device firm in the Dallas/Fort Worth area, is actively recruiting for a Principle Quality Systems Specialist. This will be 10 month contract position, and will pay $50-$60 per hour based on prior experience.

As a core member of the team, the Principle Quality Systems Specialist will coach, mentor and train colleagues. You will be expected to act as a primary contact, both internally and externally. My client will help you achieve these goals by continuous professional development throughout the project.

Among others, the Principle Quality Systems Specialist will have the following responsibilities:

  • Lead audit and inspection preparation, resolution of audit and inspection findings and works directly with auditing groups though all stages.
  • Provides ongoing support of SOP's, ensure adherence to industry standards with ISO 13485, FDA's QSR's and other quality regulations, standards, corporate policies and guidelines.
  • Prepares reports and presents technical and program information to management and team members that communicate QS/QA status and effectiveness.
  • Works closely with functional groups, including, but not limited to Quality Control, Supplier Quality, R&D Engineering, Manufacturing, Marketing and Purchasing as necessary.
  • Applies statistical methods in problem solving related to the development and application of solutions to CAPAs and other quality system activities.

The best candidates for Principle Quality Systems Specialist will have the following qualifications:

  • B.S. degree Life Science or related field
  • 7+ years of experience with Medical Device
  • Skills in quantitative and qualitative assessments, statistical analysis, knowledge and application of quality engineering.
  • Strong personal skill set; leadership, both oral and written communication, adaptable, and detail-oriented.
  • Strong understanding in QMS and well versed in CAPA

This is truly an amazing opportunity to join a high-functioning team within the leading Medical Device industry. Principle Quality Systems Specialist at this firm are offered unlimited growth potential and can help you gain market leading skills and capabilities.

If you are interested, please forward your resume and let me know a good time to speak with you.

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