Quality Engineer 1
Location
San Carlos, CA
Level
Full-Time
Department
Biotechnology
Type
Salary
$63,000 - $79,000
Job Description
Posted on:
2025-03-19
Responsibilities
- Support internal and external audits (CLIA/CAP, ISO 13485, customer).
- Assist in CAPA, Deviation, and Nonconformance investigation and reporting.
- Ensure compliance with quality systems related to CLIA, FDA QSR, ISO 13485, and HIPAA.
- Participate in managing Approved Suppliers.
- Follow established standard operating procedures and documentation practices.
- Review manufacturing/QC batch records.
- Perform other duties as assigned.
Job Requirements
- B.S. or equivalent in science, engineering, or related field.
- At least 2 years of experience in medical diagnostics, CLIA laboratory, or Life Sciences industry.
- Basic knowledge of CLIA/CAP regulations, ISO 13485 standard, and/or FDA QSRs (21 CFR 820).
- Proficiency in MS Word, Excel, PowerPoint.
- Strong technical writing and communication skills.
- Ability to work independently with strong organizational skills.
- Good judgment, attention to detail, and interpersonal skills.
