Job Description
Job DescriptionEssential Functions:
- Leads the ongoing implementation of Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices.
- Responsible for the administration of the QMS software.
- Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements.
- Integrates ISO 14971, ISO 13485, risk management and IEC 62366 usability engineering activities with Glidewell/Prismatik processes.
- Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and Prismatik framework.
- Provides CAPA, complaints, audit and overall QMS support in regards to software.
- Performs other related duties and projects as business needs require at direction of management.
Minimum Qualifications:
- Bachelor’s degree in Engineering, Biomedical, or related technical field or equivalent practical experience.
- Minimum of eight (8) years of related experience in the FDA QSR/ISO 13485 medical device industry.
- Advance knowledge with development and test requirements with recognized standards (ISO 13485).
- Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the Prismatik practices and the QMS.
Pay range: $85,500 to $125,000/yrExact compensation may vary based on skills and experience.