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QA/RA Specialist CapsoVision, lnc. Saratoga, CA Job Details Full-time $60,000 - $80,000 a year 16 hours ago Benefits Visa sponsorship Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Biology Microsoft Excel Content creation for technical audiences ISO standards Bachelor's degree Attention to detail Organizational skills Productivity software Quality audits Technical writing experience within technology Cross-functional collaboration Cross-functional communication

Full Job Description SUMMARY:

We are seeking a detail-oriented and motivated Entry-Level QA/RA Specialist to join our team. In this role, you will support both Quality Assurance (QA) and Regulatory Affairs (RA) functions to ensure our products comply with applicable medical device regulations (e.g., FDA, ISO 13485, CE Mark). This is an ideal role for a recent life science, engineering, or related graduate looking to launch a career in quality systems and regulatory compliance. Key Responsibilities Quality Assurance (QA)

• Assist in maintaining the Quality Management System (QMS) in accordance with regulatory standards (e.

g., FDA

QMSR, ISO-13485, EU MDR

).

• Help review and manage Document Control processes, including Standard Operating Procedures (SOPs), batch records, and change controls.
• Participate in Non-Conformance (NC) and Corrective and Preventive Action (CAPA) investigations.
• Root cause analyses and implementation of corrective/preventative actions for process related issues/concerns
• Support internal and external quality audit preparations and follow-up activities. Regulatory Affairs (RA)
• Assist in compiling and updating technical documentation, regulatory filings, and submissions (e.g., 510(k), CE Mark technical files, annual reports).
• Help monitor changing international and domestic regulations and standards affecting the product portfolio.
• Review product labeling, promotional materials, and packaging for regulatory compliance.
• Assist with regulatory database updates, registration renewals, and device/product listings.
• Assist with Post-Market Surveillance (PMS) Duties. Qualifications & Requirements

Education:

Bachelor's degree in Life Sciences (Biology, Chemistry, Biochemistry), Biomedical Engineering, Public Health, or a related technical discipline.

Experience:

0-2 years of experience in a regulated industry (biotech, medical devices, pharmaceuticals, or consumer health). Internships or undergraduate research experience preferred.

Skills:

• Strong technical writing and verbal communication skills.
• Exceptional attention to detail and organizational skills.
• Basic knowledge of Quality Management Systems (QMS) or FDA/ISO regulatory frameworks.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and document management systems.
• Ability to collaborate effectively in cross-functional team environments.
• Positive, results-oriented and energetic team player Preferred Qualifications
• Exposure to root-cause analysis tools (e.g., 5 Whys, Fishbone diagrams).
• Coursework or certifications in Quality Control, Regulatory Affairs, or Quality Engineering.
• Medical device experience preferred
• Internal auditing experience preferred

ISO-13485

highly preferred.

Job Type:

Full-time Pay:

$60,000.00 - $80,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance Application Question(s): Do you need visa sponsor in the future?

Experience:

Medical Device:

1 year (Required)

License/Certification:

ISO-13485

(Required)

Location:

Saratoga, CA 95070 (Required) Ability to

Commute:

Saratoga, CA 95070 (Required)

Work Location:

In person