Quality Assurance Specialist

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: Support and maintain the Quality Management System (QMS) in accordance with company procedures and applicable regulatory requirements. Assist with training documentation and quality records. Support Corrective and Preventive Action (CAPA) activities. Participate in change control processes. Manage complaints and product feedback documentation. Assist with internal and external quality audits. Review manufacturing documentation and production records. Perform quality control inspections of finished products. Review and release medical device products for distribution. Analyze manufacturing quality data to identify trends and opportunities for improvement. Support validation and ongoing maintenance of manufacturing equipment, software, and production processes. Support quality activities related to new product introductions and engineering design changes. Review verification and validation protocols and reports, risk management documentation, product requirements, specifications, and technical documentation. Maintain Design History Files (DHF) and Device Master Records (DMR). Collaborate with Engineering to ensure design changes are successfully transferred into manufacturing. Qualifications & Experience Required: Bachelor's degree in Science, Technology, Engineering, Mathematics (STEM), or a related discipline. Approximately one year of experience working in a regulated industry such as medical devices, pharmaceuticals, or biotechnology. Working knowledge of ISO 13485 and ISO 14971. Experience supporting quality systems within a manufacturing environment. Preferred: Post-graduate education in Biomedical Engineering, Quality Assurance, Regulatory Affairs, or a related field. 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.

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.

Identified from the job description. Confirm important requirements above.

• Quality Management System
• CAPA
• Change Control
• Internal Auditing
• Quality Control Inspection
• ISO 13485
• ISO 14971
• Risk Management
• Design History File
• Device Master Record
• Validation
• Verification
• Regulatory Compliance
• Manufacturing Documentation
• Technical Documentation
• Cross-functional Collaboration

Minimum education

Bachelor’s degree

Minimum experience

0+ years