Director of Compliance and QA

Full Spectrum Software - Southborough, MA (30+ days ago)


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:

  • Owner of the Quality Management System at Full Spectrum Software
  • Help company obtain ISO 13485 - 2016 certification
  • Drive company towards ISO 9001 certification
  • Ensure adherence and implementation of QMS on work performed at Full Spectrum Software
  • Work with top management to develop, plan, and implement company quality objectives and initiatives.
  • Ensure that the organization’s services meet customer requirements and applicable quality standards.
  • Stay on top of changes in quality standards and ensure the implementation of the same
  • Direct quality engineering in identifying, recommending, implementing, managing, andadministering process and software validations.
  • Create and support effective process enhancement initiatives to maintain an environment of continuous improvement throughout the organization. Provide effective leadership support, training, and guidance to all company employees.
  • Hands on software testing and validation is required
  • Be able to develop software test plans and test cases
  • Any prior experience as a SQA or SQA Lead will be a big plus

This can be a full time or contract position for the right individual.

Qualifications:

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

Education:

  • Bachelor's