ICU Medical, Inc
Salt Lake City, UT, United States
Engineering, Quality, Sciences
Senior Quality Engineer-Risk Assessment','19300345','!*!Job TitleQuality Engineer – Risk AssessmentFLSA StatusExemptPosition SummaryThe Quality Engineer will primary write risk assessments based on data generated from non-conformances, CAPAs, complaints, and post-market surveillance (working on products like our transducers, catheters, IV sets, and needleless access devices). This position will work directly with the Plant Quality Manager, Director of Quality, CAPA Coordinator, and the Complaint Team. Essential Duties & Responsibilities• Participate in daily complaint meeting• Work with Plant Quality Manager to identify non-conforming lot reports that require risk assessments to be written or updated• Work with CAPA Coordinator to assess risk and risk categories associated with CAPAs, and write or update appropriate risk assessment(s)• Hands-on product complaint analysis/investigation to become familiar with products and appropriately assess risk to write risk assessments associated with complaints and post-market surveillance data• Develop a thorough understanding of product functional requirements and design fundamentals in order to determine risk.• Demonstrate an understanding of functional impact of changes to critical dimensions of components• Prepare risk assessment reports based on data; document, assess, and address non-conformances, CAPAs, and complaints• Apply a well-rounded understanding of engineering/design specifications, principles and methods to perform engineering analyses• Work on special projects as they ariseKnowledge, Skills & Qualifications• Strong technical writing is a must• Able to write effective reports and do so in a timely, priority driven manner• Able to work effectively in a team environment with shifting priorities and deadlines• Able to prioritize and work unsupervised • Must be able to handle multiple projects in various stages of planning, execution, and implementation• Must be able to apply a well-rounded understanding of engineering/design specifications, and engineering principles and methods, to perform engineering analyses.• Able to clearly explain complex data to a non-technical audience• Excellent documentation skills• Excellent verbal and written communication skills• Proficient in Microsoft WordEducation and Experience • Bachelor’s degree in engineering science or related field from an accredited college or university. Masters preferred. Six or more years of quality engineering experience, preferably in Medical Device• Experience with strong technical writing is a must• Experience working in an FDA regulated industry is a plusTravel Requirements• Typically requires travel less than 5% of the timePhysical Requirements and Work Environment• Work is performed in a safe environment • While performing the duties of this job, the employee is regularly required to work with contaminated Medical Devices in a controlled setting• This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines• Must be able to occasionally move objects up to 15 lbs. ','','US-UT-Salt Lake City','','Full-time','Day Job','','Senior Quality Engineer-Risk Assessment
ICU Medical, Inc
Website : http://www.icumed.com
ICU Medical is in the business of making connections -- human connections. We design and make some of the world's safest, most reliable medical devices and systems for infusion therapy, oncology, and critical care applications. Our products improve patient outcomes by helping prevent bloodstream infections and protecting patients and healthcare workers from exposure to infectious diseases or hazardous drugs. Our complete product line includes needlefree vascular access devices, custom infusion systems, closed delivery systems for hazardous drugs, advanced sensor catheters and hemodynamic monitoring systems.