Full Spectrum Software is looking for Director of Compliance and Quality Assurance with strong skills and experience managing Quality Management System (QMS) as per ISO 13485 standards in the development of software solutions for medical devices. Experience as a hands-on Software Quality Assurance Engineer or Tester is required. Experience in ISO 9001 is a big plus.
The Director will be responsible for the design and achievement of company goals with respect to quality software services delivered to a wide variety of clients. The role will be responsible for hiring, training, mentoring and managing some of the staff.This individual will construct and maintain a quality management system that complies with FDA and international standards and our clients’ quality system needs while remaining lean and flexible to efficiently satisfy a broad range of clients’ business needs.
Duties and Responsibilities:
This can be a full time or contract position for the right individual.
Bachelor’s degree in Engineering, Science, or similar technical discipline
8+ years experience in Quality Management including medical device and software development
Extensive knowledge of ISO 13485 and ISO 9001
Proven managerial and leadership skills, with the ability to lead, motivate, and develop staff
Ability to speak effectively before groups of clients or employees
Solid understanding of IEC 62304 Medical Software Development Process is a plus
Experience in test automation is a plus
Experience as a hands on SQA and/or SQA Lead will be helpful
Job Type: Full-time