Quality Auditor

The Quality Auditor roles are responsible for monitoring compliance of the Quality Management System to applicable regulations through internal audits of Agiliti corporate and field offices. Provide support for all Quality policies, systems, programs, and objectives.

PRIMARY DUTIES AND RESPONSIBILITIES

Quality Auditor: Level 2

• Perform Quality Management System (QMS) internal audit activities to ISO 13485 and 21 CFR 820 standards
• Provide Quality support to external audits
• Participate in the routine review of governmental and associated industry organizations' standards, guidelines, and policies (ISO, FDA, TJC, DNV, NFPA, CMS, AAMI, CDC, AABB, etc.)
• Explain technical ideas by authoring clear and concise QMS documents, reports, procedures, work instructions, forms, medical equipment management plans (MEMPs), training materials, and internal communications using structured writing and content management
• Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends
• Participate in the creation and maintenance of Management Review materials including the oversight and reporting of Quality Objectives
• Provide Quality support and expertise to the field offices by responding to all communications received through the Quality email service
• Assist in the implementation of continuous improvements to Quality policies, systems, programs, and initiatives
• Execute complex Quality project assignments
• Lead small projects within team or across one to two departments
• Work independently; minimal daily direction required to successfully develop deliverables
• Gather usability feedback from users

This job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department.

REQUIRED EXPERIENCE

Quality Auditor: Level 2:

• Bachelor's degree in Quality Management, Engineering, Life Sciences or Business preferred
• Minimum 3-5 years Quality or other applicable experience
• ISO 13485 Accredited Lead Auditor Certification strongly preferred
• Experience conducting internal audits in accordance with ISO 13485 and/or 21 CFR Part 820 in a medical device setting strongly preferred

REQUIRED SKILLS & ABILITIES

• Strong familiarity with ISO 13485, ISO 19011, and 21 CFR Part 820 required. Familiarity with 21 CFR Part 11 preferred
• Strong communication and presentation skills, including ability to communicate effectively at all levels of the organization
• Proficient computer skills in MS Office Suite
• Ability to sit, stand, lift, bend, and stoop numerous times throughout the day
• Flexibility in work schedule to meet department needs. May require up to 50% travel.