SaMD Quality Systems Specialist - Digital Health

Whoop; Boston (MA); On-site; USD 105,000 - 135,000; Full time

Job summary

WHOOP is seeking a Quality Systems Specialist I to lead and improve the QMS for SaMD and digital health products. You will own quality processes, manage eQMS, and drive CAPAs, audits, and continuous improvement to ensure regulatory compliance and product quality.

This role is based in our Boston, MA office. The successful candidate will collaborate with Regulatory Affairs, Engineering, and Product teams to embed quality into software development and lifecycle activities while maintaining audit

Qualifications

• Bachelor’s degree in engineering, life sciences, or related technical field.
• 2+ years in quality management systems, quality assurance, or related roles within medical device, digital health, or software medical device industries.
• Knowledge of ISO 13485 and 21 CFR Part 820/QMSR; experience with MDSAP, IEC 62304, and other medical device standards preferred.
• Experience owning CAPA, complaints, audits, training, and document control.
• Experience supporting and maintaining electronic Quality Management Systems (eQMS).
• Experience supporting internal and third-party audits including regulatory inspections.
• Experience with SaMD, digital health tech, and software-focused quality systems.
• Strong organizational, communication, and project management skills.

Responsibilities

• Own and maintain QMS processes in line with ISO 13485, 21 CFR Part 820/QMSR, MDSAP, IEC 62304.
• Administer and maintain the eQMS: document control, post-market workflows, training management.
• Own core quality processes: CAPA, nonconformances, change control, records management.
• Close CAPAs, nonconformances, audits, and other quality actions timely.
• Maintain audit readiness; coordinate internal and external audits and management reviews.
• Drive continuous improvement via data analysis, trend monitoring, and RCA.
• Support post-market surveillance and quality data analysis with cross-functional teams.
• Integrate quality requirements into software development and product lifecycle.
• Develop, review, and improve SOPs and controlled docs.
• Monitor regulatory requirements and implement QMS updates.

Skills

Quality management

CAPA management

Audits

eQMS

Documentation control

Regulatory compliance

Project management

Communication

Education

Bachelor's Degree in Engineering, Life Sciences, or related field

Job description

WHOOP is seeking a Quality Systems Specialist I to lead and improve the QMS for SaMD and digital health products. You will own quality processes, manage eQMS, and drive CAPAs, audits, and continuous improvement to ensure regulatory compliance and product quality.

This role is based in our Boston, MA office. The successful candidate will collaborate with Regulatory Affairs, Engineering, and Product teams to embed quality into software development and lifecycle activities while maintaining audit