More jobs:
Quality Specialist
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-07-30
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-30
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
- Conducts compliance audits of difficult & complex documentation and data
- Approve use of Design History Records, Device Master Records, Nonconformances, Document Changes, Validations and Change Controls
- Demonstrates working knowledge of Quality Control, Manufacturing and Inventory processes
- Leads internal, external & 3rd party audits
- Reviews Customer Notifications and prepare, approve & submit data packages for external customers
- Supports internal and/or external audits in compliance with ISO 13485 and 21
CFR
820 requirements - Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners
- Assists in developing quality systems & make recommendations for improvements to existing Quality systems
- Approves compliance assessments & interfaces with other departments
- Requires BA or BS in a biological or chemical science
- Quality certification (from American Society for Quality or equivalent), is a plus
- 5-8 years related quality experience
- Working understanding of QSR & ISO requirements
- Advanced knowledge of QC, Manufacturing & Inventory processes
- Working knowledge of Microsoft Word, Excel, Power Point
- Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential
- Must demonstrate initiative, independence, balanced assertiveness, flexibility and team orientation.
Demonstrates expertise in conducting compliance audits and managing quality systems in accordance with ISO 13485 and 21
CFR
820 requirements. Possesses strong organizational skills and the ability to collaborate effectively across departments while ensuring adherence to quality control and manufacturing processes.
- Compliance Audits
- Quality Control
- ISO 13485
- 21
CFR
820 - Quality Certification
- Quality Systems Development
- Document Control
- Data Package Preparation
- Change Control
- Validation Processes
- Attention to Detail
- Organizational Skills
- Initiative
- Independence
- Team Orientation
- Quality Certification
- QSR
- Manufacturing Processes
- Inventory Processes
- 3rd Party Audits
- Regulatory Compliance
- Microsoft Word
- Microsoft Excel
- Microsoft Power Point
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