Quality Specialist

Jobtailor; San Diego (CA); On-site; USD 95,000 - 125,000; Full time

Job summary

Jobtailor is seeking a Quality Compliance Auditor in the San Diego area to perform complex audits, approve DHF/DMR usage, and support ISO 13485 and 21CFR820 compliance across departments.

The role requires 5–8 years of quality experience, a biology/chemistry background, and ASQ or equivalent certification is a plus. Proficiency with MS Office and strong organizational skills are essential.

Qualifications

• BA or BS in a biological or chemical science.
• Quality certification (ASQ or equivalent) is a plus.
• 5–8 years of related quality experience.
• Working understanding of QSR & ISO requirements.
• Advanced knowledge of QC, Manufacturing & Inventory processes.
• Proficient with MS Word, Excel, and PowerPoint.
• Strong detail orientation and prioritization in a fast-paced environment.
• Must demonstrate initiative, independence, balanced assertiveness, flexibility and team orientation.

Responsibilities

• 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 21CFR820 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.
• Appr oves compliance assessments & interfaces with other departments.

Skills

Attention to detail

Organizational skills

Initiative

Independence

Team orientation

Education

BA/BS in biological or chemical science

Quality Certification (ASQ or equivalent) preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

• 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 21CFR820 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

Requirements

• 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.

Core Competencies

Demonstrates expertise in conducting compliance audits and managing quality systems in accordance with ISO 13485 and 21CFR820 requirements. Possesses strong organizational skills and the ability to collaborate effectively across departments while ensuring adherence to quality control and manufacturing processes.

Highest-signal resume keywords

• Compliance Audits
• Quality Control
• ISO 13485
• 21CFR820
• Quality Certification

ATS Optimization Keywords

Hard Skills

• Quality Systems Development
• Document Control
• Data Package Preparation
• Change Control
• Validation Processes

Soft Skills

• Attention to Detail
• Organizational Skills
• Initiative
• Independence
• Team Orientation

Certifications & Qualifications

• Quality Certification

Industry Keywords

• QSR
• Manufacturing Processes
• Inventory Processes
• 3rd Party Audits
• Regulatory Compliance

Tools & Technologies

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint