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Job Details

Quality Director

Company: EPM Scientific
Location: Rockville
Reference: MERZ12012017720
Closing Date: 16 Dec 17
Type: Permanent
Salary (£): 100,000+
Benefits:

Job Summary:

QUALITY DIRECTORMulti-Million Medical Device CompanyRockville, MD$185,000 – $200,000 + Bonus + Benefits + Career GrowthAn expanding Medical Device company is seeking a Quality Director...

Requirements:

QUALITY DIRECTOR

  • Multi-Million Medical Device Company
  • Rockville, MD
  • $185,000 – $200,000 + Bonus + Benefits + Career Growth

An expanding Medical Device company is seeking a Quality Director to lead the team to cover all aspects of quality and regulatory systems. This company is rapidly growing, with a fantastic work-life culture, family oriented, and they offer a competitive base salary, bonus, benefits, and upward mobility within the company!

The Quality Director will be implementing all requirements to maintain compliance, communicating with FDA and European regulatory agencies, managing the Quality Management System, and will be responsible for quality and regulatory strategic direction.

The Quality Director will be responsible for the following:

  • Lead and participate in external and internal audits
  • Manage the daily execution of quality systems
  • Implement improvements to the Quality System while ensuring compliance with ISO standards and Quality System Regulations
  • Interface with contract manufacturing, as well as other critical suppliers; conduct supplier audits
  • Prepare and submit all necessary documentation supporting regulatory filings

The Quality Director will have the following requirements:

  • Training/Certification in ISO 13485 and/or FDA 21 CFR 820
  • Bachelor’s in Life Sciences or Engineering or equivalent; advanced degree preferred
  • 10+ Years experience in Medical Device industry; 3 – 5 years experience in managerial position
  • Expertise of actively working with a product development team throughout all quality system requirements: development, design, validation, verification, and design transfer
  • Knowledge of FDA Requirements within a medical product development environment

Apply for this job: Quality Director

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
EC3V 9AH
England
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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