Quality Systems Specialist I

Agiliti Health • Minneapolis, MN

2d

About The Position

The Quality Systems Specialist roles are responsible for providing support for all Quality policies, systems, programs, and initiatives. Primary Duties and 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

Requirements

• Bachelor’s degree in life sciences, engineering, or technical communications strongly preferred
• 1 -3 years Quality or other applicable experience preferred
• 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

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

Benefits

• Agiliti offers a robust suite of benefits for regular, full-time, non-union employees including: 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, and wellness programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees