Job Information
ICU Medical Engineer II, Quality in Salt Lake City, Utah
Position Summary:// The Quality (MQ) Engineer II is responsible for executing tasks to ensure newly hired MQ Engineers are adequately trained and competent to perform their jobs. The incumbent performs quality approval of change control documentation related to calibration and preventive maintenance, and is the primary training support for MQ Engineer-related tasks. The incumbent is also responsible for providing oversight and guidance in manufacturing operations to ensure GMP compliance. This person will coach manufacturing personnel on proper GMP and SOP (Standard Operating Procedures) compliance and empower them to identify and escalate quality issues, to ensure quality product. The MQ Engineer II, will also be required to write investigations when necessary and manage the associated corrective actions and document change controls for the department. Database administration responsibilities for MQ specific databases and programs. This role is 100% onsite at our Salt Lake City, UT manufacturing facility. Essential Duties & Responsibilities: · Assists with and evaluates On-the-Job Training competencies of MQ Engineers/Supervisors in training (wet side and dry side operations). · Reviews and approves Preventive Maintenance and Calibration change control documentation. · Conducts evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure procedures are being followed in accordance with GMP compliance. · Conducts real-time batch record reviews in assigned areas. · Reviews equipment logbooks and evaluates adjustments for impact to product quality. · Creates, reviews, and revises SOPs and assist with investigations as applicable. · Performs data analysis, identifies corrective/preventive actions, and implements process improvements with a focus on quality processes. · Provides input and decision making for quality in the manufacturing areas with regard to manufacturing and deviations. Provides corrective actions as necessary. · Monitors assigned area(s) for compliance to SOPs and cGMPs – equipment, documentation, and personnel. · Performs other related duties as assigned or required. · Also provides similar quality oversight functions for the Round Rock facility as assigned or required. Knowledge, Skills & Qualifications: · Strong oral/written communications skills and leadership skills required. · Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative required. · Ability to work well with all levels of personnel throughout the facility. · Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment. · Must be able to function independently with minimum supervision. · Must be able to evaluate options/ideas/proposals and present recommendations to management. Education and Experience: · BA/BS required, preferably in Engineering or the sciences (Biology, Chemistry, Microbiology, Pharmacy). · Previous pharma experience. · Experience in a clean room environment desirable. · Minimum of 2 years’ experience required in Quality Assurance and/or experience working in an FDA-regulatory environment 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. Title: Engineer II, Quality Location: UT-Salt Lake City Requisition ID: 24300791