Quality Systems Specialist I

Agiliti; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Systems Specialist to support quality policies and systems. This role involves participating in Quality Management System activities, authoring clear QMS documents, and providing expertise to field offices. The ideal candidate will have a strong commitment to patient safety and product quality, ensuring compliance with various standards and guidelines. If you have a background in life sciences or engineering and are looking to make an impact in the healthcare sector, this opportunity is perfect for you. Join a team dedicated to excellence and innovation in quality management.

Qualifications

• 0-3 years of experience in Quality or applicable fields.
• Strong preference for candidates with a Bachelor’s degree.

Responsibilities

• Support QMS activities including document change and records management.
• Assist in internal and external ISO 13485 audits of QMS.

Skills

MS Office Suite

Electronic ERP system

Quality Management System compliance

Technical writing

Education

Bachelor’s degree in life sciences

Bachelor’s degree in engineering

Bachelor’s degree in technical communications

Job description

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

PRIMARY DUTIES AND RESPONSIBILITIES

Quality Systems Specialist: Level 1

1. 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)
2. Support post market surveillance including recall/modification management, preventative maintenance intervals, equipment incidents, and complaints
3. 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
4. Participate in the creation and maintenance of Management Review materials including the oversight and reporting out of Quality Indicators (QIs)/metrics
5. Provide Quality support and expertise to the field offices by responding to all communications received through the Quality email service or phone support lines
6. Assist in internal and external ISO 13485 audits of QMS
7. Monitor governmental and associated industry organizations’ standards, guidelines, and policies (ISO, FDA, TJC, DNV, NFPA, CMS, AAMI, CDC, AABB, etc.)
8. Participate in tasks associated with Infection Control, Bloodborne Pathogen laws, and equipment cleaning validations

REQUIRED EXPERIENCE

Quality Systems Specialist: Level 1

1. Bachelor’s degree in life sciences, engineering, or technical communications strongly preferred
2. 0 – 3 years Quality or other applicable experience

REQUIRED SKILLS & ABILITIES

1. Proficient computer skills in MS Office Suite and in an electronic ERP system
2. Ability to sit, stand, lift, bend and stoop numerous times throughout the day
3. Flexibility in work schedule in order to meet department needs; may require up to 10% travel.
4. 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

This job description in no way states or implies 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