Quality Systems Engineer

Technimark - Greensboro, NC (30+ days ago)3.6


Job Summary:

This position is located in Asheboro, NC. Maintains the Quality Management System and Operations Manual for the Asheboro campus ensuring policies and procedures are current and in compliance with relevant standards. Gathers data and information, including audit findings, customer complaints, and customer surveys, necessary to assess the performance of the QMS. Makes recommendations regarding system improvements and training required. Emphasizes and ensures the awareness of customer requirements throughout the organization is promoted.

Knowledge/ Experience/ Skills:

4 year degree in science, math or engineering or a 2 year degree with 4 years of experience in quality systems required. General knowledge of quality systems, manufacturing systems, ISO standards and application of FDA regulations for applicable products preferred. Ability to develop written procedures and perform technical report writing required. Knowledge of CAPA systems and supplier management programs preferred. Good communication and interpersonal skills required. Computer experience with Microsoft products and the ability to develop reports, spreadsheets, and presentations required.

Essential Duties & Responsibilities:

  • Maintains the Operations Manual for the Asheboro campus.
  • Promotes and audits continual improvement efforts for the company.
  • Supports systems required to maintain external registration such as ISO, food safety, and FDA.
  • Executes and organizes activities related to the Internal Audits, customer audits, and 3rd party audits.
  • Supports and ensures the Customer Complaint, Corrective Action, and Preventative Action programs are followed according to the Quality system.
  • Supports the disposition activities of non-conforming products according to the Quality System.
  • Develops and administers quality system training for all employees.
  • Provides training related to the QMS.
  • Supports new certification initiatives.
  • Supports the Supplier Quality Program
  • Establishes and maintains relationships with customers to address issues concerning quality system.
  • Assists with product development and its impact on the QMS.
  • Assesses regulatory compliance activities within TM and its supplier base.
  • Develops material for and participates in Management Review Meetings.

Job Type: Full-time

Experience:

  • Technical Writing: 1 year

Education:

  • Associate