Director of QA and Regulatory Affairs

Technical Source is currently in search of Director of Quality & Regulatory Systems for our medical device manufacturing client located here in the Raleigh, NC area. The qualified candidate will have senior level experience as a quality manager or senior manager in a medical device engineering and manufacturing environment.

Responsibilities of the Director of Quality & Regulatory Systems include:

  • Own global quality business initiatives and strategies from end to end
  • Oversee international quality standards and regulations internal audits
  • Provide leadership and strategic guidance to the company for anything Quality Assurance and/or Regulatory functions, practices, systems and procedures

 

Qualifications of the Director of Quality & Regulatory Systems include:

  • 5+ years’ experience in senior management in an enterprise medical device engineering and manufacturing background
  • Expert knowledge of FDA Quality System Requirements, all applicable medical device ISO standards
  • Strong focus on internal audits of QMS compliance standards in FDA and internationally regulated situations
  • Bachelor’s degree in related field, Masters preferred

 

Compensation for the Director of Quality & Regulatory Systems includes:

  • $135,000 – 150,000 per year based on experience
  • Full Medical, Dental, Vision, 401K and complete comprehensive compensation plan

 

Key Words:

Director, senior manager, QMS, Quality Engineer, Quality Assurance Specialist, Medical Device, Medical Imaging, Imaging, CAPA, Quality Plans, quality assurance, FDA, product development, medical device development, design, engineer, electro-mechanical, quality engineer, product design, product engineer, manufacturing, compliance, regulatory affairs, RA, QE, QA, full time, benefits, medical, 401K, direct hire, permanent