Medical Device QA Specialist (Class II)

SleepRes™, Inc.; San Francisco (CA); Vor Ort; USD 90.000 - 115.000; Vollzeit

Zusammenfassung

SleepRes, Inc. is seeking a Quality Assurance Associate to support the QMS for Class II medical devices.

You will coordinate document control, manage training programs, and administer the eQMS under the guidance of the Quality Manager. You will collaborate with Quality, Regulatory, Engineering, Operations, and Customer Care to maintain audit-ready records and support design control, risk management, and software compliance.

Qualifikationen

• 3–5 years of experience in medical device quality systems.
• Experience with document control, training coordination, and electronic quality management systems (eQMS).
• Knowledge of FDA QMSR, 21 CFR Part 820, and ISO 13485.
• Knowledge of ISO 14971 risk management and IEC 62304 medical device software lifecycle.

Aufgaben

• Administer document control activities within the eQMS, including creation, review, release, and archival.
• Coordinate and maintain the training matrix, onboarding, recurring training, and role-based curricula.
• Administer the eQMS, manage user access, workflows, and training modules; support data integrity.

Kenntnisse

Document control

Training coordination

eQMS administration

Complaint handling

Design control

Risk management

Software lifecycle

FDA QMSR familiarity

Ausbildung

Bachelor's degree in engineering

Jobbeschreibung

SleepRes, Inc. is seeking a Quality Assurance Associate to support the QMS for Class II medical devices.

You will coordinate document control, manage training programs, and administer the eQMS under the guidance of the Quality Manager. You will collaborate with Quality, Regulatory, Engineering, Operations, and Customer Care to maintain audit-ready records and support design control, risk management, and software compliance.