Quality Assurance Specialist II, Medical Devices
Employment type
Full-time
Work setting
On-site
Location
San Diego, CA
Schedule
Day shift
Posted
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Job overview
The Quality Assurance Specialist II, Medical Devices role is onsite in San Diego, CA; compensation is not specified. The specialist supports quality and regulatory compliance for medical devices at Wondfo USA.
What you'll do
- Support the Quality Management System
- perform batch and finished-device release activities
- coordinate line clearances and in-process verifications
- review records for GMP compliance
- maintain document control, training, traceability, and validation records
- support NCR, deviation, and CAPA processes
- assess quality events
- contribute to complaint management
- and assist with audits and regulatory inspections.
What we're looking for
- Skills & competencies
- quality assurance specialist iimedical devicessan diego cawondfo usaquality management systemgmpbatch releasedocument controlcapavalidationregulatory compliancemedical device quality
- Work arrangement
- Weekend coverage required
Why this role
The posting requires a bachelor’s degree in science or a related field and at least two years of quality assurance experience in medical devices, biotech, or a related industry. ISO 13485 knowledge is preferred.
About the employer
Wondfo USA is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.
Additional details
- Industry sector
- 33
- Industry
- Electromedical and Electrotherapeutic Apparatus Manufacturing
- Occupation code
- 19-4099.00
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Listing ID: d156392b-79dd-4c6e-98de-9f5dc0e239c4