The Quality System Specialist II supports the implementation, maintenance, and
continuous improvement of the Quality Management System (QMS). This role contributes
to the effective execution of quality processes to ensure compliance with applicable
regulatory requirements (e.g., FDA, ISO standards) and internal procedures.
The position involves a combination of process ownership and cross-functional support
across key QMS elements, including quality events, supplier quality activities, audits,
training, and document control systems.
Essential Job Functions
Location: Memphis, TN, US
- Coordinate and support quality processes related to product quality events,
including complaint handling and follow-up activities
- Contribute to continuous improvement of QMS processes to enhance compliance,
efficiency, and overall product quality
- Maintain high standards for documentation and data integrity within the eQMS
Trustworthiness
- Ensure quality activities are performed in compliance with applicable regulatory
requirements (e.g., FDA, ISO standards) and internal procedures
- Support accurate, complete, and audit-ready documentation across QMS
processes
- Participate in supplier quality activities, including audit support and tracking of
actions, ensuring transparency and accountability
Drive Results
- Support the execution and timely closure of core QMS processes, including CAPA,
change control, and document control activities
- Track and follow up on quality system actions to ensure completion and
effectiveness
- Support preparation of quality metrics and data for routine quality reviews and
decision-making
May 2025
Collaboration
- Work cross-functionally to resolve quality issues and support implementation of
process improvements
- Support internal and external audit activities, including preparation and follow-up
- Assist in the administration of training programs and document lifecycle processes,
partnering with stakeholders across the organization
Additional functions may be added at discretion of Management
Skills
- Strong organizational and coordination skills across multiple processes
- Ability to work effectively across functions and support multiple stakeholders
- Strong written and verbal communication skills for documentation and reporting
Experience
- 5+ years in Quality Assurance or a related function within a regulated environment
- Technical writing experience, including development or revision of controlled
documents (e.g., SOPs, work instructions)
- Experience supporting or participating in regulatory inspections (e.g., FDA or other
regulatory bodies) preferred
- Familiarity with quality management system processes (e.g., CAPA, investigations,
audits, training, document control)
- Experience with electronic Quality Management Systems (e.g., ETQ or similar
platforms)
- Experience supporting internal audits, supplier quality activities, or training
programs preferred
Education:
- Education: A college degree or equivalent experience.
- Licenses/Certificates: Industry Quality Certifications (i.e., ASQ)
- Technology/Equipment: Microsoft Office Applications, Warehouse Management
Applications, eQMS software
Experience:
- Technical writing experience (specifically SOP writing experience)
- Experience hosting or supporting FDA or other regulatory agency inspections
May 2025
Physical Demands:
- Primarily performs work in an office and/or manufacturing environment
- Prolonged periods of sitting and working at a computer
- Frequent use of hands and fingers for typing, documentation, and data entry
- Ability to occasionally stand, walk, and move throughout office and manufacturing
areas
- May be required to review documentation or systems for extended periods to
support quality activities
- Ability to occasionally lift and/or move up to 15 pounds
- Visual acuity sufficient to review detailed documentation, electronic records, and
data
Working Conditions:
- Primarily office-based with regular interaction within manufacturing and controlled
production environments
- Routine presence on the production floor to support quality activities such as
audits, investigations, and process observations
- Standard Monday–Friday schedule, with flexibility to support production needs,
audits, or project timelines
- Frequent interaction with cross-functional teams, including Manufacturing,
Engineering, and Supply Chain
- Exposure to various manufacturing environments, including controlled or regulated
areas, in accordance with site safety and compliance requirements
Reporting Structure:
- This position reports to the Director of Engineering
