Medical Device External Quality Manager (Onsite)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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 no