Website AbbVie
AbbVie
Company : AbbVie
Job Description
Purpose:
The Manager, Medical Device External Quality is part of AbbVie’s External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties. In this capacity, the Manager, Medical Device External Quality, champions best practices related to sustaining product quality, equipment qualification, and manufacturing process validations.
As such, the Manager, Medical Device External Quality works closely with AbbVie’s Contract Manufacturing Organizations (CMOs), relevant third-party suppliers (e.g., custom components), and internal stakeholders to ensure compliance with defined specifications and regulatory requirements. The position also supports Quality Management System activities related to the CMOs, including – but not limited to – CAPAs/NCRs, Change Control, Complaints, Product Release, Supplier Quality Agreements, etc. Additionally, the Manager, Medical Device External Quality, may support New Product Introduction activities, with particular emphasis on transfer-to-manufacturing. The Manager, Medical Device External Quality provides strong technical leadership in the TPQ Quality function amongst peers, ensuring that functional activities are compliant and aligned with overall company goals and strategies.
Responsibilities:
Manages CMOs and/or third-party suppliers to assure timely and compliant release of commercial products and/or components in accordance with defined specifications and processes.
Oversee CMOs and/or third-party suppliers to ensure that non-conformances, CAPAs, Reworks, and deviations are accurately documented, reviewed, and approved as well as resolving compliance issues related to commercial product and/or custom components
Supports New Product Introduction (NPI) activities
Develops and maintains supplier Quality Technical Agreement. Review and approve changes to supplier processes which impact device and/or component manufacture.
Review and approve technical protocols, reports, and specifications, as appropriate.
Supports Quality Systems group during Regulatory inspections (i.e., serve as product SME)
Participates in the development of global Product Quality Assurance strategy to support medical devices and/or combination products produced at third party manufacturing (TPM) facilities.
Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers if required.
Interfaces with Global Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Support Supplier Audit function during CMO site audits.
Leads management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Champions development and maintenance of KPIs and trend analysis at supplier site, as applicable