Position Summary
The Quality Engineer will support the ICU Quality Engineering Department and report to the Quality Manager. The Quality Engineer is responsible for sustaining manufacturing and validations through adherence to established design control processes, good quality and documentation practices. The key responsibility of this position is to exercise judgement and take action while adhering to defined quality procedures during project support & improvement. The Engineer I will complete basic projects assigned by more experienced engineers and managers. Works on projects/matters of limited complexity in a support role while being closely managed.
This role is based 100% onsite at our Dublin, OH manufacturing facility.
Essential Duties & Responsibilities
• Immediate expectations:
o Support initiatives for continuous quality improvements
o Under the guidance of the Quality leadership, work to improve performance of manufacturing systems, e.g. yield, cycle-time, quality requirements, maintenance needs
o Support project timelines and milestones and bring them to completion on time and within budget
o Assist in completion of CAPA tasks and deliverables (Corrective and Preventive)
o Quality technical expert for a manufacturing production line
o Create and edit documents to support Quality
o References existing work to complete similar projects. Improves on previous work.
o Provides input to the product teams regarding the development of new designs, methods or processes.
o Works under supervision of more experienced engineers. Regular assignments are completed with minimum supervision.
• Long term expectations:
o Initiate and manage projects with adherence to program-management guidelines
o Participate in vendor assessment and review of materials/machine technical information
o Build productive relationships internally and externally
o Work with Product, Manufacturing, and Molding Engineers on qualification activities for new or modified processes and equipment.
o May assist in training new employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
o Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
o Work on special projects as they arise
Knowledge, Skills & Qualifications
• Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.)
• Technical writing competency
• Has engineering foundation.
• Expected to spend majority of time learning and best practices.
• Has a basic understanding engineering discipline.
• Willingness to learn/understand big picture.
• Ability to complete projects with minimum supervision.
• Requires the ability to provide input and recommendations that impact the completion of project goals.
•
Education and Experience
• Bachelor's degree from an accredited college or university in Engineering required.
• 0-2 years' experience in the Medical Device or Engineering Industry
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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