Toronto, Ontario, Canada · On-site
We are a team of passionate medical and technological innovators on a mission to improve patient treatment and outcomes with cutting-edge medical devices like the FloPatch. FloPatch is the world’s first wireless Doppler …
Skills: Quality Management System, CAPA, Change Control, Internal Auditing, Quality Control Inspection
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The specialist will maintain the Quality Management System and support CAPA, change control, and audit activities. They are also responsible for reviewing manufacturing records and releasing medical device products for distribution.
A Bachelor's degree in a STEM field and approximately one year of experience in a regulated industry like medical devices are required. Knowledge of ISO 13485 and ISO 14971 is essential, with a postgraduate degree preferred.
We are a team of passionate medical and technological innovators on a mission to improve patient treatment and outcomes with cutting-edge medical devices like the FloPatch. FloPatch is the world’s first wireless Doppler ultrasound system designed to support the clinical management of critically ill patients. The wearable sensor enables real-time functional hemodynamic monitoring for patients requiring cardiopulmonary and fluid resuscitation.
The successful candidate will assist Flosonics Medical in introducing FloPatch to the world.
We are seeking a detail-oriented and motivated Quality Assurance Specialist to join our Quality & Regulatory Affairs team. This role plays a critical part in ensuring our medical devices continue to meet the highest standards of quality, safety, and regulatory compliance while supporting the successful growth of our manufacturing operations and product portfolio.
The ideal candidate enjoys working cross-functionally, has strong organizational skills, and is passionate about maintaining quality systems that enable innovative medical technologies to reach healthcare providers and patients around the world.
Reporting to the Quality & Regulatory Affairs Manager, you will work closely with Engineering, Manufacturing, Operations, and Regulatory Affairs to support both ongoing production and new product development initiatives.
Key Responsibilities:
Qualifications & Experience
Required:
Preferred:
We wish to thank all applicants, however, only those selected for an interview will be contacted directly. If you are selected to participate in the recruitment process, accommodations are available upon your request to meet your accessibility needs.
FloPatch by Flosonics Medical
Flosonics Medical is a venture-backed start-up that develops and commercializes wearable sensors, which improve clinical management of critically ill patients inside and outside of the hospital. Our FloPatch technology enables real-time functional hemodynamic monitoring for patients requiring cardiopulmonary and fluid resuscitation. FloPatch is the only solution suitable for use inside and outside the hospital. We are a privately-owned Canadian company with offices in Sudbury and Toronto.
Offices: 325 Front St W, Toronto, Ontario M5V 2Y1, CA · 56 Walford Rd, Greater Sudbury, Ontario P3E 2H3, CA
FloPatch by Flosonics Medical
Flosonics Medical is a venture-backed start-up that develops and commercializes wearable sensors, which improve clinical management of critically ill patients inside and outside of the hospital. Our FloPatch technology enables real-time functional hemodynamic monitoring for patients requiring cardiopulmonary and fluid resuscitation. FloPatch is the only solution suitable for use inside and outside the hospital. We are a privately-owned Canadian company with offices in Sudbury and Toronto.
Offices: 325 Front St W, Toronto, Ontario M5V 2Y1, CA · 56 Walford Rd, Greater Sudbury, Ontario P3E 2H3, CA
