Quality Specialist III - Compliance

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solutions Inc is seeking a Quality Specialist III in San Diego, CA. The Quality Specialist III will be responsible for ensuring compliance with applicable domestic and international standards and regulations through review of Device History Records (DHRs) for products manufactured at the GDS San Diego site.  Perform Enterprise Resource Planning (ERP) transactions such as product usage decision and releases product to inventory.   Reviews and approves product expiration date extension reports.   Tracks KPIs and provides feedback to cross-functional teams.  Owns nonconformance and CAPA records. Supports Quality Inspection of materials as needed.

To succeed in this role, individuals must have at least a BA or BS in a biological or chemical science, Quality certification (from American Society for Quality or equivalent), is a plus. Along with 5-8 years related quality experience and working understanding of QSR & ISO requirements.

Primary Responsibilities:

• Reviews and approves Design History Records (DHRs), Device Master Records, Document Changes, Validations and Change Controls.                                   
• Ownership, management, and processing of nonconformances, Out-of-Tolerance Reports, and CAPA records. Supports Quality Inspection as needed.
• Conducts compliance audits of difficult & complex documentation and data and 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.
• Serves as QA interface with limited responsibilities to other departments.
• 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 and business partners for complaints, investigations, etc.
• Chairing meetings as appropriate such as Complaint Review Board (CRB), Material Review Board (MRB) and Product Quality Committee (PQC), Change Control Board (CCB), and other meetings.
• Prepares appropriate Agendas and meeting minutes.
• Monitors the progress of items on the meeting Agendas and reports progress, as appropriate.
• Chairs meetings & represents QA as an extended core team member on Core team and cross functional special project teams.
• May conduct new employee quality system or procedural training and develop department training programs.
• Conducts complex technical troubleshooting activities & investigation analysis.
• Performs technical support of QA Systems.
• Develops, analyze, trend, maintains & reports department metrics, as needed.
• Reviews and assesses the appropriateness of document changes in accordance with inte