Clinical Engineering Quality Analyst
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Overview
Responsibilities
This is a remote position.
Job Summary / Purpose
This position performs a variety of national office functions in support of the CommonSpirit Clinical Engineering (CE) department. Specifically this includes data standardization and ongoing integrity of the Computerized Maintenance Management System (CMMS) data; assists with the national process for oversight of device recalls provides direction and support as needed for incident investigations provides regulatory support for compliance issues and questions as well as assisting with national CE policies development and review relating to topics such as data integrity regulatory issues quality and standardization.
Essential Key Job Responsibilities
- Assists with the standardization of CMMS data. Specifically related to:
- a. Device name manufacture & model
- b. Modality HIPAA designation and rules
- c. Risk Scoring Risk Factor & PM Procedures
- d. Develops and evaluates national Alternative Equipment Maintenance (AEM) programs
- Assists with the process for a cost-effective timely and customer satisfying transition of database operations for all new sites being converted onto the CMMS platform. Specifically:
- a. This position will work collaboratively with the new site leadership and with the CE-IS Helpdesk on all new site acquisition/data conversions.
- b. This process requires providing oversight to the standardization process so as to maintain accuracy and integrity of the data being standardized nationally
- Assists in data integrity for CMMS data on an ongoing basis. Provides detailed review and analysis of new equipment works with the local CE department leadership to ensure accurate creation of above listed standardization elements for all new devices/manufacturers/models.
- Develop and implement a national office process for oversight of device recalls across the system.
- Provide direction to local CE departments and other CHI interests regarding incident investigations. Involvement with ECRI AAMI and the FDA will likely be a component of this responsibility.
- Provides support to local CE departments regarding regulatory questions/issues i.e. CMS conditions of participation regulatory (TJC DNV State etc.) standards clarification assistance with regulatory survey refutations RFI action plans etc.
- Integrated in CommonSpirit clinical engineering advocacy work (such as speaking engagements white papers Board participation etc.) with a wide variety of industry advocacy groups and organizations promoting industry activities and advancing CHI interests and influence throughout the industry. Provides representation for CHI to committees boards and other activities as well as presentations and education to the industry and communities.
- Ensures smooth communications and reporting to and from sites across the system. This includes providing updates to the field concerning standardization updates and changes to the CMMS database policy/process updates regarding the areas of operational oversight listed above.
- Networks with peers to gain innovative ideas and sourcing of information.
- Works with sustainability manager on quality issues or standards relating to medical devices.
- Collaborates with other Patient Safety groups within CommonSpirit (i.e. Infection Prevention IRIS Review Board Cyber Security etc.)
Qualifications
- Bachelors Degree required but equivalent related work experience may be considered.
- Three years of experience as a Clinical Engineer or Technician. Quality Engineer or Technician with experience in Quality Management Systems (QMS) may also be acceptable with a working knowledge of ISO 9001 and ISO 13485.
- Computer Skills: Advanced: must be familiar with wide variety of applications (ie SQL Excel Pivot Tables Vlookups BI etc.).
- Language Ability: Intermediate: Ability to read and interpret documents such as safety rules operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
- Math Ability: Intermediate: Ability to calculate and analyze a wide range a data type financial quantitative pattern analysis formula calculations. Ability to compute rate ratio and percent and to create charts graphs and other visual aids in presenting data.
- Reasoning Ability: Advanced: Ability to deal with complex problems involving a wide range of factors and variables in stressful situations.
- Computer Skills: Advanced: must be familiar with wide variety of applications operating systems clinical applications cybersecurity applications and technologies.
- Reliable transportation required.
#LI-Remote
#LI-CSH
Required Experience:
IC
Key Skills
- Gas Chromatography
- Laboratory Experience
- Archival Standards
- ELISA
- Test Cases
- Analytical Chemistry
- Quality Assurance
- Spectroscopy
- Quality Control
- cGMP
- Selenium
- Western Blot
About Company
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