Quality Systems Specialist I, Digital Health

What this role involves

WHOOP is hiring a Quality Systems Specialist I to maintain and improve the Quality Management System for Software as a Medical Device and digital health products. The role involves owning quality processes like CAPA, complaints, and audits, ensuring compliance with regulations like ISO 13485 and 21 CFR Part 820. The position is based in Boston, MA, and requires relocation if necessary.

Skills this posting asks for

• iso 13485
• 21 cfr part 820
• qmsr
• mdsap
• iec 62304
• eqms
• document control
• capa
• complaint management
• training management
• change control
• records management
• post-market surveillance
• audit management
• root cause analysis
• software as a medical device
• digital health
• software development lifecycle
• regulatory affairs
• project management

Requirements

• 2 years of experience
• Level: mid
• Remote policy: onsite

From the employer’s posting

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. WHOOP is looking for a Quality Systems Specialist I to be a core m…