Website AbbVie
AbbVie
Company : AbbVie
Job Description
Medical Device Quality Intern Overview
Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical / medical device industry. This is a reality for AbbVie’s Interns.
The Pharmacovigilance, Patient Safety, Epidemiology, and Quality (PSEQ) organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile and ensure quality standards of AbbVie products to protect patients worldwide.
The Medical Device Combo Product Research and Development Quality Assurance (MDCP RDQA) organization works 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.
The intern 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.
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.
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.