About this role
Serve as QA on cross-functional combination product and medical device development teams for late-stage programs. Execute quality system requirements including design control, risk management, supplier management, and audit/investigation readiness.
Key Responsibilities
- Perform design control and risk management activities according to AbbVie's Quality System
- Partner with Quality and Operations to ensure design control documentation and design change control requirements are met
- Perform third party supplier management activities such as review 3rd party design control activities
- Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure
- Lead/assist preparation for regulatory agency and internal audits and conduct investigations for IRRs, NCRs, Observations
Technical Overview
Apply AbbVie's Quality System to run design control, risk management, and design change control activities, including traceability/linkages and Design History File (DHF) improvement. Support regulatory submission documentation and lead or participate in audits and investigations (IRRs, NCRs, Observations).
Ideal Candidate
The ideal candidate is a senior quality engineering professional with 6+ years in manufacturing, quality, or engineering, experienced with combination product and medical device development. They lead design control and risk management activities within a quality system, manage design change control and design history file gaps, and support audits and investigations including IRRs and NCRs.
Must-Have Skills
6+ years of overall experience in ManufacturingQuality or EngineeringPerform design control and risk management activities according to AbbVie's Quality SystemApply knowledge of global regulationsguidanceand Corporate and Function standardsConductleador participate in investigations for IRRsNCRsObservationsetc
Nice-to-Have Skills
Bachelor's degreepreferably in BiologyChemistry or Engineering
Tools & Platforms
Design History FileRisk ManagementTraceability/Linkages
Required Skills
quality system requirementscombination product developmentmedical device developmentdesign controlrisk managementtraceability/linkagesdesign change controldesign history filedesign change impact assessmentsthird party supplier managementregulatory submission documentationdesign history file gap closureregulatory agency auditsinternal auditsNotified Body auditsinvestigationsIRRsNCRsObservationsdepartmental change controlproceduresformsglobal regulationsquality/compliance managementAPI manufacturingBulk Drug manufacturingfinished goods manufacturing
Hard Skills
quality system requirementscombination product developmentmedical device developmentdesign controlrisk managementdesign control documentationRisk ManagementTraceability/Linkagesdesign change controldesign change impact assessmentsthird party supplier managementdesign history file (DHF)regulatory submission documentationgap identification and improvement opportunitiesprocess improvementquality/process improvementsglobal regulationsguidancecorporate and function standardsregulatory agency auditsinternal auditsNotified Body auditsinvestigationsIRRsNCRsObservationschange control activitiesreview and approve changeslate-stage development projectsproceduresformsdocument writing and revisionAPIBulk DrugFinished goods manufacturingquality/compliance managementcompliance with worldwide Combination Product and Medical Device Regulationsensure products developedmanufacturedtested and procured and data generated are compliant
Soft Skills
cross-functional collaborationcommunication (verbal and written)problem solvinganalytical skillsinterpersonal relationsnegotiationlead and participate independently on development and process improvement teams
Keywords for Your Resume
Senior Quality EngineerDesign QualityLate Stage DevelopmentQAquality systemcombination productmedical devicedesign controlrisk managementdesign change controldesign history filetraceabilitytraceability/linkagesthird party supplier managementregulatory submission documentationregulatory agency auditsinternal auditsNotified BodyauditsinvestigationsIRRsNCRsObservationschange controldesign change impact assessmentsproceduresforms
Deal Breakers
6+ years of overall experience in Manufacturing, Quality or Engineering, Must be able to perform design control and risk management activities according to AbbVie's Quality System, Must be able to support audits and investigations for IRRs, NCRs, and Observations
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