Lead and develop DELFI’s Design Quality, Risk Management, Process Validation, and Equipment Qualification programs from a Quality perspective, ensuring compliance with regulatory requirements.
- Provide Design Quality leadership and guidance for product development (includes LDT and IVD), design control, risk management, process validation/controls, and equipment qualification.
- Provide Design Quality leadership and guidance for IVD product development in compliance with FDA 21 CFR 820 QMSR/ISO 13485.
- Support the development teams in aligning product development execution strategy with Design Control and Risk Management procedures.
- Provide guidance, training, review, approve user needs, design input, design control plans, requirements, specifications, protocols/reports, design outputs, design transfer, and risk management documents.
- Lead in partnership with the cross-functional team by facilitating and supporting risk activities, including FMEAs- dFMEA, pFMEA, and use-related risk analysis.
- Bachelor’s degree in Science, Engineering, or a related field
- Master’s degree
- Nice to have: Molecular diagnostics
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