Responsibilities

• Perform QA activities related to design transfer and change management for combination products and medical devices.
• Ensure compliance with company policies and procedures and perform design control and risk management per AbbVie\'s Quality System.
• Maintain design history file documentation; ensure design control documentation and change control requirements are met.
• Manage third-party supplier design control activities; support regulatory submission documentation.
• Serve as primary quality lead for design transfer activities enabling product launches, including internal and external transfers.
• Support equipment qualifications (IQ/OQ/PQ) and process validations; own change plans and coordinate cross-functional impact assessments; track closure.
• Identify gaps and improvement opportunities within DHF and risk management; initiate assignments and lead process improvement teams.
• Monitor effectiveness of processes and projects; write or revise policies, processes, and procedures; apply global regu

Responsibilities

• Perform QA activities related to design transfer and change management for combination products and medical devices.
• Ensure compliance with company policies and procedures and perform design control and risk management per AbbVie\'s Quality System.
• Maintain design history file documentation; ensure design control documentation and change control requirements are met.
• Manage third-party supplier design control activities; support regulatory submission documentation.
• Serve as primary quality lead for design transfer activities enabling product launches, including internal and external transfers.
• Support equipment qualifications (IQ/OQ/PQ) and process validations; own change plans and coordinate cross-functional impact assessments; track closure.
• Identify gaps and improvement opportunities within DHF and risk management; initiate assignments and lead process improvement teams.
• Monitor effectiveness of processes and projects; write or revise policies, processes, and procedures; apply global regu

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