Vacancy expired!
Job Description: SMCI is seeking a Principal Quality Engineer to ensure quality and compliance associated with software medical devices, to develop, maintain, and continuously improve the software medical device and digital health product quality capability, to ensure compliance with procedures and regulatory expectations for existing and new software medical device and digital health product programs, and to develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches.
Responsibilities:
Benchmark with industry regarding quality and compliance models for software medical devices and digital health products
Accommodate Agile software development methodology
Ensure inspection readiness and maintain CE marks for existing software medical devices
Train and mentor relevant staff for development and succession planning
Maintain and resource program and project quality support portfolio
Collaborate with Senior Management, data management and presentation, provide backup support to other Quality focus areas
Work in partnership with the DH&DQ Leadership to develop business plans that cultivate staff development and supports the direction of the business
Plan and lead all aspects of major change efforts in the digital health space
Skills
Experience with digital devices, health technology, products, mobile medical apps,
Deep experience with software medical device quality and compliance concepts
Strong project management skills / ability to lead and/or lead all aspects of numerous projects simultaneously.Required Skills: Digital Devices, Health Technology, Medical Device. Don't hesitate! Submit your resume today. SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm. (No third parties, please)(H1 sponsorship currently unavailable)(Local candidates only, please) Vacancy expired!