Hiring: Quality Lead, Requirements and Specifications Management (Assay) Company: QuidelOrtho Location: Rochester, NY Job Posted Time: 2026-09-11 15:08:19 Employment Type: On-site Target Skills & Keywords : Product Management, R, Root Cause Analysis, Six Sigma, Systems Engineering About the job Experience: •7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries. Required Skills: •This position will be onsite at any major site. •Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs. •Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements. •Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. •Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle. •Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS). •Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits. •Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements. Qualifications: •Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. •Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise. •Internal: Operations, R&D, Commercial, Regulatory Affairs, Quality & Compliance teams globally and regionally •External: Regulatory agencies, Notified Bodies •Typical office or laboratory environment. May involve virtual collaboration across multiple global sites. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!