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Quality Site Lead

Date Posted: 7/23/2021

Job #1586620
Permanent
Manassas, Virginia
Manager

* This company is specifically seeking candidates with U.S. military experience *

 

 

What You Will Do:

Manage plant quality systems (including ISO documentation, records retention, etc.) and plant quality personnel to ensure that plant product and process compliance to regulatory, customer and company standards.

  • Responsible for ensuring regulatory compliance to all aspects of ISO13485 and 21 CFR 820 and all applicable regulations and guidance documents.
  • Leads all quality teams (Quality Assurance, Quality Engineering and Quality Control leads.)
  • Continuously improves quality function spending to help the plant lower its costs.
  • Oversees the validation program and directly supports the Solutions Plant Quality Manager with regard to the site risk management procedure.
  • Provide support for the regulatory approval for the manufacture of custom products; gathers necessary information regarding intended use of product and supports regulatory approval for development and labeling of new products and supports regulatory approval for all documents-both technical/marketing and controlled documents as needed.

 

Education and Skill Requirements:

  • REQUIRED: Bachelor’s degree (preferable in Life Sciences, Chemistry or Engineering)
  • 5+ years quality, engineering or operations experience within a manufacturing environment.
  • At least 2+ years of managerial or supervisory experience.
  • Audit/inspection experience and familiarity with 21 CFR parts, 820, 210/211, ISO13485 preferred.
  • Strong knowledge base in all aspects of Quality (including validation, calibration, and quality control.)

 

Title: Quality Site Lead

Location: Manassas VA

Client Job ID: 1586620

#LucasHMG

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