Sr. Quality Engineer leading design control activities across Veracyte’s IVD product lifecycle. Ensuring compliance with regulatory requirements in a hybrid work environment across the United States.
Responsibilities
Lead the design control activities across Veracyte’s IVD product lifecycle.
Ensure compliance with ISO 13485, IVDR, FDA QSR, ISO 14971 and other global regulatory requirements.
Serve as the primary Quality partner to R&D and cross-functional teams.
Drive robust design control execution, effective risk management, and sustained audit readiness.
Participate in internal and external audits, serving as the SME for design control and risk management.
Requirements
Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field.
7+ years of experience in Quality Assurance or Quality Engineering in the medical device or IVD industry.
In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and ISO 14971:2019 risk management.
Hands-on experience with risk management per ISO 14971, design history files, verification & validation, CAPA, and change control.
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