Director of Quality Assurance
Healthy.io is one of the first companies in the world to successfully turn a smartphone camera into a medical device, enabling faster treatment and improved care for patients globally . Our products combine computer vision and machine learning technology with best-in-class UX design to create new clinical pathways through smartphone powered urinalysis and digitized wound management.
The Director of Quality Assurance (QA) will be responsible for leading Healthy.io's Quality Management System (QMS) activities that comply with EN ISO 13485:2016 standard, FDA QSR regulations, and other applicable standards for the assurance of the quality of company products.
Role & Responsibilities
Managing and supporting company processes, with an emphasis on:
- Management Review
- Corrective and Preventive Actions (CAPAs)
- Non-conforming products
- Internal auditing
- Design Control and Software Development Life-Cycle (SDLC) and the creation and maintenance of products’ Design History Files (DHFs)
- Creation and maintenance of Device Master Records (DMRs) and Device History Records (DHRs)
- Engineering Changes (ECOs)
- Handling complaints
- Employee’ Qualifications
- Supplier and subcontractor evaluations according to the EN ISO 13485:2016 standard, FDA QSR regulations, and other applicable standards
- 5-8 years of QA management experience in medical device companies; experience in software-based medical device companies is an advantage.
- Previous experience with FDA QSR regulations; past experience commercializing products in the US and FDA inspections is a plus.
- Experience in quality systems complying with EN ISO 13485:2016 standard and the MDR, IVDR European regulations.
- Academic degree in exact sciences such as chemistry or biology is an advantage.
- Attention to detail and ability to manage multiple tasks.
- Ability to lead and manage independently.
- Full professional fluency in English.