About this role
Quality Lead, Requirements and Specifications Management (Assay) at Orthoclinical. Location: Rochester, New York, United States. Role: driving compliance, improving processes, monitoring quality Requirements: Bachelor's in life sciences/engineering required, 7+ years quality/compliance experience in medical device/IVD/biopharma, strong knowledge of ISO 13485/FDA 21 CFR 820/IVDR, experience driving QMS improvements and using data to inform decisions. Category: Quality Assurance Seniority: Senior Level Certifications: lean six sigma, pmp Commitment: Full Time Workplace: Onsite Languages: English