Our client is looking to bring on a Sr. Director of Quality who thrives in a fast-paced startup environment. As a pivotal member of our team, you will wear multiple hats, contributing not only to quality assurance but also to the overall growth and success of our company. You are a proactive problem-solver, excellent communicator, and enthusiastic about learning and adapting to new challenges.
Responsibilities:
- Facilitate, maintain, and implement Best in Class Quality Management improvements to quality operations while maintaining compliance
- Take a leadership role in achieving strategic quality initiatives
- Provide leadership, direction, and mentorship to quality personnel
- Assure timely lot release of commercial products
- Responsible for the collection, analysis, and actions taken for Quality/ business metrics
- Support, participate, and defend operational quality management system areas during audits as the subject expert.
- Meet completion dates for assigned projects, internal and external audit observations related to operations quality, CAPA plans, and procedural updates
- Continually identify and implement improvements and changes to current operational processes
Education:
- BS/BA degree in biology, engineering, or equivalent scientific discipline.
Experience:
- Minimum of 15 years’ experience in Quality Engineering in Medical Device Industry