Director, Quality Systems

An innovating neurotechnology company is currently seeking an experienced Quality Systems Director. Reporting to the Vice President of Clinical Operations, you are a key participant on product development and process improvement teams.

You will also provide support and guidance on quality issues to the manufacturing team, including master validation planning, design control and procedural recommendations for standard operating procedures and protocols. You will monitor the validation and implementation of new equipment and process changes and approve validation results in technical summary reports.
REQUIREMENTS
For this position, you must have a BS in Engineering or related degree and 8-12 years of medical device industry experience.

You must also have experience with sterile medical devices. Your knowledge of, or experience in, the CNS field or implantable pacemakers/stimulators is a strong plus. Experience with the development and start-up of quality systems in a new facility and with six sigma or total quality management systems is also desirable.

Other skills necessary for you to be successful in this position include:
Excellent communication skills with senior management, medical professionals and researchersListening skill and ability to translate desires for information into results based on solid conclusions founded on solid science and dataExcellent reading, writing, problem-solving and communication skills in the English languageThe ability to perform your work independently with little supervisionYou should be also highly organized and be detail oriented