As a Medical Device & Combination Product Quality Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical and medical device industry. You will support the Medical Device Combo Product Research and Development Quality Assurance (MDCP RDQA) organization, working collaboratively and strategically with colleagues in R&D, Operations, Regulatory Affairs, Medical Safety and more to develop and launch new AbbVie medical device products to patients worldwide.

The role of MDCP R&D Quality is to ensure products are designed to be safe and effective, while also ensuring development efforts comply with applicable standards and regulations. The group is also focused on harmonizing quality processes across many diverse sites to ensure the needs of each site are represented in global procedures. We support the development of a variety of medical devices in the Aesthetics space, including fillers, plastics (implants / tissue expanders), regenerative medicine (tissue products), and electromechanical equipment (cryolipolysis and rapid acoustic pulse wave technology for body contouring). 

Key Responsibilities:

The intern will support a team of R&D QA development partners around the globe and will partner with Quality Engineers and Managers at the site to:

• Collaborate with Design teams, provide technical support, and facilitate the successful execution of the Design Control Process for complex electromechanical medical devices containing hardware, software, electrical and mechanical components various medical devices and combination products. 
• Create Quality Engineering deliverables required within the product development process.
• Support Design Verification and Validation activities, including review of verification & validation protocols and reports
• Assist in the analysis of product requirements and specifications. Participate in product design reviews and team meetings.
• Provide subject expertise and input in the following areas: Biocompatibility strategy, including requirements, protocol, and report; Shelf-Life Studies strategy, including accelerated and real-time; Cleaning Validation.
• Ensure that technical information is accurate and in compliance with quality and regulatory requirements. 
• Review Design Changes post design transfer.
• Work on process improvements globally or at the site level.
• Facilitate tracking of key QA decisions and regulatory body feedback for continuous improvement opportunities.
• Prepare information for communication and knowledge sharing using various methods (e.g., presentations, written messages, training, etc.)
• Learn about R&D QA quality systems in a regulated environment.