Hiring: Quality Lead Design Transfer & Tech Transfer Strategy Company: QuidelOrtho Location: Rochester, NY Job Posted Time: 2026-09-11 15:08:19 Employment Type: Contract Target Skills & Keywords : R, Regulatory Compliance, Risk Management, Six Sigma About the job Experience: •10+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries Required Skills: •This individual is responsible for fostering a culture of engagement, collaboration, and performance. By integrating technical expertise and data-driven insights, the Principal Quality Partner ensures that Quality systems deliver sustainable business and compliance outcomes. •This position will be onsite in Rochester, NY or Raritan, NY. •Serve as the primary Quality partner to the Technology Transfer team, providing strategic guidance and oversight throughout assay design transfer and tech transfer activities. •Lead development and execution of comprehensive design transfer and technology transfer quality strategies that ensure compliant, sustainable product realization. •Partner cross-functionally with Design Quality, Quality Operations, R&D, and Manufacturing teams to ensure alignment on design transfer deliverables, risk management, and process capability expectations. •Provide expert interpretation of applicable global regulatory and quality system requirements (e.g., ISO 13485, IVDR, FDA QSR) as they relate to design transfer, process transfer, verification/validation, and manufacturing readiness. •Support global audit and inspection activities as a subject matter expert and auditee for design transfer, tech transfer, and related quality system elements. •Proactively identify quality gaps, systemic risks, and continuous improvement opportunities within design transfer frameworks and lead cross-functional teams to implement solutions.‑improvement opportunities within design transfer frameworks and lead cross-functional teams to implement solutions. Qualifications: •Strong analytical and systems‑thinking skills to evaluate end‑to‑end product realization pathways. •Demonstrated capacity to anticipate risks in design transfer and proactively implement mitigation strategies. •Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. •Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise. •Internal: Tech Transfer, Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, and other Quality & Compliance teams globally and regionally •External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. •The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. 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!