Jr. Quality Specialist

at  Flosonics Medical

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 Jr. Quality Specialist will play an essential role on our growing team. The successful candidate will contribute to our organizational growth by supporting ongoing regulatory activities and participating in quality initiatives. Our ideal team member is passionate about their work, has a strong sense of teamwork, and a strong attention to detail. We are looking for someone who is interested in using their unique skills to contribute to the development of our quality system.

REQUIREMENTS:

• Bachelor’s Degree in STEM (science, technology, engineering, or mathematics)
• Preferred – Postgraduate in Quality Assurance and/or Regulatory Affairs
• Preferred – 1 year experience working in a regulated industry (medical device, pharmaceutical, etc.)
• Preferred - knowledge of ISO 13485 and ISO 14971
  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

Provide support for the following activities within the quality management system:

• Training and documentation
• Corrective and preventive actions
• Change control
• Complaints and product feedback
• Quality audits

Provide support for quality activities related to manufacturing including:

• Review of manufacturing records
• Nonconforming products and corrective actions
• QC inspection of product
• Review and release of medical device products
• Analysis of manufacturing data
• Validation and maintenance of manufacturing equipment, software and processes

Provide support for quality activities related to new product introduction and product design

changes including:

• Review of verification and validation protocols and reports
• Review of risk management files
• Review of requirements and specifications
• Review of technical documentation and reports
• Maintenance of design history files and device master record