Agiliti · 15 hours ago
Quality Systems Specialist I
Eden Prairie, MN
Full-time
Onsite
New Grad, Entry Level
$43K/yr - $112K/yrAgiliti is a company focused on providing quality healthcare solutions, and they are seeking a Quality Systems Specialist I. This role involves supporting various Quality Management System activities, including document management, post-market surveillance, and ensuring compliance with industry standards.
Health Care
Responsibilities
Participate in all Quality Management System (QMS) activities including document change management, records management, training/competency, non-conforming material reports (NCMRs), and Corrective and Preventive Actions (CAPAs)
Support post market surveillance including recall/modification management, preventative maintenance intervals, equipment incidents, and complaints
Explain scientific and technical ideas by authoring clear and concise QMS documents, equipment handling procedures, forms, cleaning policies, medical equipment management plans (MEMPs), safety alerts, training materials, user guides, internal communications, and customer letters through the use of structured writing and content management
Participate in the creation and maintenance of Management Review materials including the oversight and reporting out of Quality Indicators (QIs)/metrics
Provide Quality support and expertise to the field offices by responding to all communications received through the Quality email service or phone support lines
Assist in internal and external ISO 13485 audits of QMS
Monitor governmental and associated industry organizations’ standards, guidelines, and policies (ISO, FDA, TJC, DNV, NFPA, CMS, AAMI, CDC, AABB, etc.)
Participate in tasks associated with Infection Control, Bloodborne Pathogen laws, and equipment cleaning validations
Qualification
Required
Participate in all Quality Management System (QMS) activities including document change management, records management, training/competency, non-conforming material reports (NCMRs), and Corrective and Preventive Actions (CAPAs)
Support post market surveillance including recall/modification management, preventative maintenance intervals, equipment incidents, and complaints
Explain scientific and technical ideas by authoring clear and concise QMS documents, equipment handling procedures, forms, cleaning policies, medical equipment management plans (MEMPs), safety alerts, training materials, user guides, internal communications, and customer letters through the use of structured writing and content management
Participate in the creation and maintenance of Management Review materials including the oversight and reporting out of Quality Indicators (QIs)/metrics
Provide Quality support and expertise to the field offices by responding to all communications received through the Quality email service or phone support lines
Assist in internal and external ISO 13485 audits of QMS
Monitor governmental and associated industry organizations' standards, guidelines, and policies (ISO, FDA, TJC, DNV, NFPA, CMS, AAMI, CDC, AABB, etc.)
Participate in tasks associated with Infection Control, Bloodborne Pathogen laws, and equipment cleaning validations
Proficient computer skills in MS Office Suite and in an electronic ERP system
Ability to sit, stand, lift, bend and stoop numerous times throughout the day
Flexibility in work schedule in order to meet department needs; may require up to 10% travel
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Management System, Quality Policy, and all other documented quality processes and procedures
Benefits
Health insurance options for Medical, Dental & Vision plans
Short- and Long-Term Disability plans
Flexible Spending Accounts
Health Savings Accounts
Life Insurance Options
Paid Time Off
401K Saving Plan with employer match
Employee Discounts
Tuition Reimbursement
Daily Pay program
Employee Assistance Program
Wellness programs
Company
Agiliti
Agiliti is a provider of health care technology management and service solutions to the health care industry.
Founded in 1939
5001-10000 employees
H1B Sponsorship
Agiliti has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2024-02-26Acquired
2021-04-22IPO
Leadership Team
Tom Boehning
Chief Executive Officer and Board Member
Tom Leonard
CEO and Board Member
Recent News
Medical Xpress - latest medical and health news stories
2025-10-02
Company data provided by crunchbase