Quality Assurance Specialist – Medical Device
Pay Rate: $20–$30/hr. (depending on experience)
Are you detail-oriented, collaborative, and passionate about quality assurance in the medical device industry? We’re seeking a dedicated Quality Assurance Specialist to join our team in San Diego, CA. This fully onsite role supports post-market complaint handling and documentation review for a leading medical device organization.
This position is designed to cover a leave of absence and is expected to last 6 months. While extension or conversion may be considered based on performance and budget, it is not guaranteed.
Responsibilities
- Monitor the Complaint Handling inbox for new complaints and adverse event reports
- Generate complaints in the Electronic Quality Management System (eQMS) and update the Master Complaint Tracker
- Attach relevant documentation to eQMS (e.g., PC/AE reports, follow-ups, assessments, log files)
- Organize and maintain complaint folders in SharePoint for investigation and collaboration
- Perform Device History Record (DHR) reviews for complaint investigations
- Update complaint summaries with administrative details including device and report information
Requirements
- 1–3 years of Quality Assurance experience in the pharmaceutical or medical device industry
- Strong proficiency in Microsoft Excel, Word, and SharePoint
- Familiarity with QSRs and complaint handling processes
- Ability to manage multiple tasks with high self-motivation and attention to detail
- Excellent written, verbal, and interpersonal communication skills
- Experience with OMNIFY or other eQMS platforms is a plus (training provided)
- Bachelor’s degree in a scientific discipline preferred; relevant experience in complaint handling also considered
What We Offer
- Medical insurance
- Vision insurance
- 401(k)
If you're ready to make an impact in a fast-paced, quality-driven environment, we’d love to hear from you. Apply now or reach out for more information!