QMS Specialist: Document Control & Change Expert

Elos Medtech AB; Memphis (TN); On-site; USD 55,000 - 75,000; Full time

Job summary

Elos Medtech AB is seeking a Quality System Specialist I to support the implementation and maintenance of the Quality Management System. The role coordinates document control, change management, and supplier quality activities to ensure regulatory compliance and data integrity.

Ideal candidates will have 2+ years in QA within a regulated environment, strong technical writing skills, and experience with ETQ or similar eQMS platforms. On-site in Memphis, TN, with standard hours.

Qualifications

• Bachelor's degree or equivalent required.
• Experience in a regulated environment (FDA/ISO) preferred.
• Technical writing experience with SOPs and controlled documents.
• Experience with document control, revision management, and audits.
• Familiarity with quality management systems (ETQ or similar).

Responsibilities

• Coordinate and support document control, periodic review, and change management activities.
• Maintain accurate, audit-ready documentation and data integrity in the QMS.
• Assist in supplier quality documentation and supplier audits oversight.
• Support change control board activities and ensure timely progression of changes.
• Prepare for internal and external audits with documentation and system support.

Skills

Quality Assurance

Document control

Change management

Audit support

Technical writing

Cross-functional

Regulatory compliance

ETQ experience

SOP writing

Microsoft Office

Education

Bachelor's degree or equivalent

Tools

ETQ

eQMS software

Microsoft Office

Job description

Elos Medtech AB is seeking a Quality System Specialist I to support the implementation and maintenance of the Quality Management System. The role coordinates document control, change management, and supplier quality activities to ensure regulatory compliance and data integrity.

Ideal candidates will have 2+ years in QA within a regulated environment, strong technical writing skills, and experience with ETQ or similar eQMS platforms. On-site in Memphis, TN, with standard hours.