Director of Quality Job Vacancy in Carterra, Inc Salt Lake City, UT 84103 – Latest Jobs in Salt Lake City, UT 84103

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Company Name :
Carterra, Inc
Location : Salt Lake City, UT 84103
Position : Director of Quality

Job Description : Position: Director of QualityFLSA Status: ExemptDepartment: OperationsLocation: Salt Lake City, UTFull/Part Time: Full timeCOMPANY PROFILECarterra is a fast growing medical device technology company located in Salt Lake City, Utah. The Carterra name is based on two core concepts: Cartography (mapping) and terra (worlds); literally meaning “mapping worlds.” This represents the Company’s exciting new high-speed, high-resolution label-free biosensor technology, which is being used by leading pharmaceutical and biotechnology companies to thoroughly explore new worlds in biotherapeutic drug discovery that were previously impossible to investigate. Our products allow researchers to identify potential targets early in the drug discovery process where risks and costs can be significantly mitigated.JOB SUMMARYDirector of Quality role is responsible for the organization’s ISO-9001 Quality Management System, coordinating work of consultants/notifying bodies, managing quality/compliance resources and maintaining the on-going quality system maintenance including, but not limited to; policy and process documentation, external audits, internal audits, supplier audits and management reviews. Position is also responsible for managing aspects of the Quality Control function, such as; quality planning, incoming inspections, supplier quality and utilizing critical quality data to work with manufacturing and engineering to drive improvements. Coordinate supporting our Salt Lake Facility operation through creation and maintenance of medical device manufacturing documentation, such as Device History Records.JOB DUTIES AND RESPONSIBILITIESOwns the revision, documentation and on-going maintenance of Carterra’s Quality Management System.Ensures the organization remains compliant with the QMS through internal audits and coordinating external audits with notifying bodies.Leads and conducts the Management Review Process at the appropriate executive team meetingDirects processes relating to Complaint Management, Engineering Change Orders, Document Control, CAPA and Regulatory Control.Works closely with R&D during new product launches to ensure proper medical device design documentation is being recorded and retainedWorks closely with manufacturing to ensure proper quality controls are in place both internally and at suppliersWorks closely with manufacturing to ensure proper Device History Records are being recorded and retainedWorks with appropriate groups to conduct FMEA and develop quality plans to drive improvements in quality and lower riskAnalyzes critical quality data from suppliers, product installations and manufacturing in order drive improvementsOwns and drives improvement on critical quality related metricsFocus on continuous improvement and support the company’s Lean Manufacturing PhilosophyMaintain a clean well organized manufacturing environmentUnderstands there will be other duties and responsibilities as assignedOperates with a “safety first” approachAlways acts and behaves in the company’s best interest and is an outstanding representative for the organizationSKILLS AND EXPERIENCE5 – 10 years experience in an ISO manufacturing environmentMedical device instrumentation preferred· Excellent written and verbal communication skills· Ability to work effectively in cross functional teams; R&D, Marketing, suppliers· Energetic with a positive attitude· Motivated to drive results and execute with high level of personal accountability and integrity· Enjoys working in a small, fast growing companyEDUCATIONBachelors degree in Scientific, Engineering or related fieldPHYSICAL REQUIREMENTSAble to lift 25 lbs.Ability to travel < 25%NOTICEThis job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for their job. Duties, responsibilities, and activities may change at any time with or without notice.Job Type: Full-timeBenefits:401(k)Dental insuranceFlexible spending accountHealth insuranceHealth savings accountLife insurancePaid time offVision insuranceSchedule:8 hour shiftMonday to FridaySupplemental Pay:Bonus payExperience:ISO: 3 years (Preferred)Work Location: One location This post is listed Under  Utah jobs

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