Descripción del Trabajo
Participates in system and device product development teams to ensure regulatory, quality, and safety standards are incorporated into product specifications and manufacturing processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Works with customers and Business Units to create Quality and Manufacturing plans providing clear, unambiguous, and mutual understanding of responsibilities and requirements for Jabil service(s) provided.
· Works with design and process engineers to develop risk assessments.
· Supports sales presentations, contract reviews, and quoting.
· Coordinates regulatory compliance aspects of product launch.
· Collaborates with the customer and internal engineering teams to continuously improve engineering services and regulatory compliance of the devices manufactured.
· Identifies and ensures compliance with all laws and regulations that apply to medical device manufacturers.
· Provides fellow employees and customers with guidance and support to ensure compliance with GMP and the QSR.
· Supports internal, external, and regulatory audits with the FDA.
· Helps define and develop regulatory, quality, and safety training for the plant.
· May perform other duties and responsibilities as assigned.
· Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
· Ability to define problems, collect data, establish facts, and draw valid conclusions.
· Ability to operate a personal computer including using a Windows based operating system and related software.
· Advanced PC skills, including training and knowledge of Jabil’s software packages.
· Ability to write simple correspondence. Read and understand visual aid.
· Ability to apply common sense understanding to carry out simple one- or two-step instructions.
· Ability to deal with standardized situations with only occasional or no variables.
· Ability to read and comprehend simple instructions, short correspondence, and memos.
· Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
· Ability to compute rate, ratio, and percent and to draw and interpret graphs.