JOB SUMMARY
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. JOB QUALIFICATIONS KNOWLEDGE REQUIREMENTS 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.
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