Quality Specialist

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 #J-18808-Ljbffr