vexos | Quality Systems Specialist

Vexos™ is a trademark registered in the US Patent and Trademark Office.

© Copyright 2019 Vexos. All rights reserved.  |  Privacy Policy  |  Legal

Quality Systems Specialist - Full Time
 

SUMMARY

 

The Quality Systems Specialist reports directly to the Director of Quality and is responsible for the Quality Management System, the Corrective and Preventative Action program, and performance data analysis. The Quality Systems Specialist will lead multifunctional groups in problem solving activities using standard methods such as 8D, Ishikawa diagrams, and FMEA.

RESPONSIBILITIES

  • Draft, review and maintain the Quality Management System controlled documentation in accordance with the ISO 9001 Standard, ISO 13485 Standard and QSR 21 CFR 820 Regulation

  • Initiate and manage internal, external and supplier corrective actions along with dispositioning customer complaints and internal nonconforming material

  • Perform internal and external audits, as required by the Standards and Regulation, for compliance and improvement opportunities.

  • Analyze performance data on a routine basis to prioritize and execute improvement activities.

  • Initiate and lead problem solving initiatives using industry standard methods such as 8D, Ishikawa diagrams.

  • Identify and coordinate fulfillment of training requirements per quality system requirements.

  • Distribution of responsibilities to personnel while being accountable for their results.

 

REQUIREMENTS

  • Minimum of 2 years of Quality Systems Specialist experience

  • Minimum of 2 years of ISO or QSR compliance experience

  • Fluent in Microsoft Word, Excel and PowerPoint

  • Pivot Table and data analysis in Excel

  • Internal and external auditing

  • Professional writing skills with experience in drafting Quality Management System procedures.

  • Experience in the electronics industry is preferred

QUALIFICATIONS

  • Bachelor’s Degree, preferably Electronics and/or Engineering

 

POSITION LOCATION

  • Lagrange, OH

 

As an equal opportunity employer, Vexos is committed to a diverse workforce.