Quality Specialist

Grifols

Quality Specialist conducting compliance audits and ensuring adherence to quality standards at Grifols, a global healthcare company.

Posted 7/23/2026full-timeSan Diego • California • 🇺🇸 United StatesMid-LevelSenior💰 $97,000 - $115,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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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 AuditsQuality ControlISO 1348521CFR820Quality Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Systems DevelopmentDocument ControlData Package PreparationChange ControlValidation Processes

Soft Skills

Attention to DetailOrganizational SkillsInitiativeIndependenceTeam Orientation

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Certifications & Qualifications

Quality Certification

Industry Keywords

QSRManufacturing ProcessesInventory Processes3rd Party AuditsRegulatory Compliance

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

Medical
Dental
Vision
Life insurance
PTO
Paid holidays
Up to 5% 401(K) match
Tuition reimbursement