Senior Engineer, Quality - Lifecycle Management

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 Senior Quality Engineer is responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc. 

Responsibilities

• Perform QA activities related to Combination Product and Medical Device Design Transfer and Change Management:
  • Ensure compliance with company policies and procedures.
  • Perform design control and risk management activities according to AbbVie's Quality System
  • Maintain DHF documentation
  • Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
  • Perform 3rd party supplier management activities such as review 3rd party design control activities
  • Support the creation of regulatory submission documentation
• Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie.
• Support equipment qualifications (IQ/OQ/PQ) and process validations.
• Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor them to ensure timely closure.
• Identify gaps/improvement o