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Clinical IT Quality Business Analyst QMS Biotechnology

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Minneapolis, MN

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Clinical IT Quality Business Analyst (QMS) | Biotechnology
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Minneapolis
MN
Job #700761953
Clinical IT Quality Business Analyst (QMS) | IoT Biotech | Minneapolis, MN (1-year contract-to-perm)
Clinical IT Quality Business Analyst Quality Management Systems QMS OLA SLA Medical Devices risk compliance audits SOX Sarbanes Oxley quality validation time management clinical applications testing Product Lifecycle Management PLM Application Lifecycle Management ALM CobiT ITIL PMP
POSITION DESCRIPTION: Expectations for this position include working knowledge of local and some of the global, regulations as they pertain to quality areas with primary emphasis on clinical processes. This position requires the ability to support the IT Clinical area systems validations, maintenance, strategies and accurate review of specific documentation as required by the IT quality processes. The position requires the understanding of auditing and investigation techniques to ascertain potential areas of risk, qualify their severity and address gaps in a methodical way to reduce overall organization exposure. Communication, collaboration, and organization skills are crucial for the fulfillment of this position. Attention to detail and timely completion of planned activities are necessary for the success of the candidate in this role.
Clinical IT Quality Business Analyst Quality Management Systems QMS OLA SLA Medical Devices risk compliance audits SOX Sarbanes Oxley quality validation time management clinical applications testing Product Lifecycle Management PLM Application Lifecycle Management ALM CobiT ITIL PMP
POSITION RESPONSIBILITIES: 75% Functional (quality & compliance reporting, QMS, audits, quality validation life cycle, strong communication, presentation & analytical skills, and time management) 25% technical (familiar with IT systems and clinical applications testing) Overall responsibilities of this Quality Analyst position include: This includes those within the Global IT Quality Management Systems (QMS) but may also include other policies and procedures within the Corporate Quality Management System. Providing the necessary support to enable the Clinical IT Team to make changes or implement new systems in compliance with our IT quality processes and with applicable regulations and standards Enforcing full adherence to our quality management system policies, processes, and procedures Improves first pass yield quality by analyzing the documentation submitted for review and working with customers to improve critical areas. Provide first local response to the support of the Clinical IT Track and report quality deliverables review metrics per OLA/SLA Contribute to training on IT processes to support project documentation authors in effort to improve overall quality of documentation QA is reviewing/approving Understands and remains knowledgeable on all applicable policies and procedures pertaining to the specific functional area being supported. This helps to ensure our compliance to regulatory requirements and applicable standards.
Clinical IT Quality Business Analyst Quality Management Systems QMS OLA SLA Medical Devices risk compliance audits SOX Sarbanes Oxley quality validation time management clinical applications testing Product Lifecycle Management PLM Application Lifecycle Management ALM CobiT ITIL PMP
EXPERIENCE: Masters/Bachelor’s Degree 4 years business analyst/ Clinical IT Systems, Quality Management Systems (QMS) or Medical Devices QA quality assurance or information technology experience Experience leading Quality and / or audit efforts in a regulated environment Quality validation and compliance process lifecycle (risk analysis, code reviews, SOX, Product Lifecycle Management (PLM) or Application Lifecycle Management (ALM) 5 years in working with quality, manufacturing or clinical business processes
Clinical IT Quality Business Analyst Quality Management Systems QMS OLA SLA Medical Devices risk compliance audits SOX Sarbanes Oxley quality validation time management clinical applications testing Product Lifecycle Management PLM Application Lifecycle Management ALM CobiT ITIL PMP
DESIRED/PREFERRED QUALIFICATIONS: Certifications with CobiT, ITIL, PMP helpful Ability to apply advanced in-depth knowledge of quality assurance practices across Quality, Manufacturing Execution or Clinical IT Systems Solid understanding of the quality regulations and auditing techniques required for the medical device industry Demonstrated analytical thinking, process mapping, process improvement and problem solving skills Ability to create and deliver presentations up to the Director level in the organization Excellent communication skills (oral, business writing, presentations and listening) Strong influencing and negotiation skills High energy and motivation with an ability to adapt to change Provides solutions to a wide range of difficult problems using multiple root cause analysis techniques (e.g., 5 whys, fishbone diagram, etc.) Analyzes complex issues and significantly improves, changes, or adapts existing methods Works independently or collaboratively to determine and develop approaches to solutions with very little to no supervision or direction. Exerts significant influence in the organization to help establish and meet quality objectives and long range goals. Determines and pursues courses of action necessary to obtain desired results Expected to provide guidance about quality related work activities Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to processes or programs. As functional subject matter expert on quality, may lead sessions with internal auditors and may be in front of an external regulatory agency. Facilitate timely issue resolution and escalation, as appropriate Ability to manage multiple, complex priorities Developed interactive skills (e.g., instruction, presentation, conduct training, interviewing, and meetings) and interact effectively with all levels of management Key Words: Clinical IT Quality Business Analyst Quality Management Systems QMS OLA SLA Medical Devices risk compliance audits SOX Sarbanes Oxley quality validation time management clinical applications testing Product Lifecycle Management PLM Application Lifecycle Management ALM CobiT ITIL PMP Interested or know someone who is please send updated resumes with acceptable and desired hourly rate to: ~~~. Regards, Bob A. Russ West Coast Manager of Recruiting Entegee | ITG-InSource Technical Group ~~~ Toll Free: ~~~ Local: ~~~ Cell: ~~~ Email: ~~~ Entegee, Inc. | ITG-InSource Technical Group is an Equal Opportunity Employer.
Updated 07/13/2018

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