AbbVie
Senior Quality Engineer
AbbVie, Chicago, Illinois, United States,
Job Description
Purpose:
The Senior Quality Engineer is responsible for carrying out the Quality Assurance functions within the Global team including management of change plans (internal and supplier initiated), performance of change/product impact analysis, complaint analysis, resolution of internal & supplier NCRs, Deviations, corrective and preventive action for events, leading and participating in investigations, review and approval of test methods and product specifications, support quality plans, and assurance of cGMP and AbbVie policy compliance for the area of responsibilities. Supports the team by reviewing and approving validation protocols and reports. Other quality assurance tasks assigned by the functional leadership.
Responsibilities:
Responsible for implementing and maintaining the effectiveness of the Quality System.
Support and ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
Ensure investigations of the Exception Reports (ERs)/Supplier Events are completed thoroughly and documented accurately and are included in the CAPA system. Performs product impact analyses for the ERs.
Maintains an effective and cooperative relationship with other Quality areas, and cross functional teams (internal and external).
Owns and manages the Change Plan (CP) process and execution for the function. Ensure timely completion of the CP tasks. Co-ordinate and present in the Cross Functional Team (CFT) and Change Review Board (CRB) meetings.
Review/approve standard operating procedures; ensures procedures comply with policy and make sense.
Manage the Pre and Post Market Reviews for the products within the functional area responsibilities. Support Design Transfer Reviews.
Support and oversee field complaints and data analysis for the complaints. Share updates and present information to various leadership forums.
Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA’s. Develops and implements statistical quality programs and process monitoring systems.
Support supplier batch review and release process.
Purpose:
The Senior Quality Engineer is responsible for carrying out the Quality Assurance functions within the Global team including management of change plans (internal and supplier initiated), performance of change/product impact analysis, complaint analysis, resolution of internal & supplier NCRs, Deviations, corrective and preventive action for events, leading and participating in investigations, review and approval of test methods and product specifications, support quality plans, and assurance of cGMP and AbbVie policy compliance for the area of responsibilities. Supports the team by reviewing and approving validation protocols and reports. Other quality assurance tasks assigned by the functional leadership.
Responsibilities:
Responsible for implementing and maintaining the effectiveness of the Quality System.
Support and ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
Ensure investigations of the Exception Reports (ERs)/Supplier Events are completed thoroughly and documented accurately and are included in the CAPA system. Performs product impact analyses for the ERs.
Maintains an effective and cooperative relationship with other Quality areas, and cross functional teams (internal and external).
Owns and manages the Change Plan (CP) process and execution for the function. Ensure timely completion of the CP tasks. Co-ordinate and present in the Cross Functional Team (CFT) and Change Review Board (CRB) meetings.
Review/approve standard operating procedures; ensures procedures comply with policy and make sense.
Manage the Pre and Post Market Reviews for the products within the functional area responsibilities. Support Design Transfer Reviews.
Support and oversee field complaints and data analysis for the complaints. Share updates and present information to various leadership forums.
Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA’s. Develops and implements statistical quality programs and process monitoring systems.
Support supplier batch review and release process.