Quality Systems Specialist

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 is one of the world’s leading development and manufacturing partners for companies in the medical technology sector. With sites in Switzerland, Sweden, Denmark, Germany, China, and the United States, we specialize in the production of implants, instruments, and components for medical technologies.

We are looking for individuals who share our values — passion, trust, and results — so we can grow together and achieve even greater success.

QUALITY SYSTEM SPECIALIST I

The Quality System Specialist I supports the implementation and maintenance of the Quality Management System (QMS). This role is responsible for the coordination and execution of document-centric quality processes, ensuring compliance with applicable regulatory requirements (e.g., FDA, ISO standards) and internal procedures. The position provides foundational support across QMS elements including document control, change management, and supplier quality activities.

Essential Job Functions

Passion

• Coordinate and support quality system activities related to document control, periodic review, and change management processes
• Maintain high standards for documentation accuracy, completeness, and data integrity within the eQMS
• Contribute to continuous improvement of QMS processes and tools Trustworthiness
• Ensure controlled documents and records are maintained in compliance with internal procedures and regulatory requirements
• Support accurate, complete, and audit-ready documentation across QMS processes
• Assist in tracking and maintaining supplier quality records and documentation Drive Results
• Administer document control processes, including routing, revision control, and approval workflows
• Coordinate periodic document reviews to ensure continued suitability and compliance
• Support execution of change management activities, including tracking and documentation of changes through the Change Control Board
• Manage and track Supplier-Initiated Change Requests (SICRs), ensuring timely progression and closure May 2025 Collaboration
• Work cross-functionally to ensure timely completion of document updates, reviews, and approvals
• Support supplier audit activities, including scheduling, documentation, and follow up actions
• Assist in internal and external audit preparation by providing document and system support Additional functions may be added at discretion of Management Skills
• Strong organizational and coordination skills across multiple processes
• Attention to detail with a focus on documentation accuracy, completeness, and data integrity
• Ability to work effectively across functions and support multiple stakeholders
• Strong written and verbal communication skills for documentation and reporting Experience
• 2+ years in Quality Assurance or a related function within a regulated environment
• Experience with document control or administrative quality processes, including revision control, record management, or document lifecycle activities
• Experience supporting change management processes, including tracking and coordination of changes
• Familiarity with quality management system processes (e.g., document control, change control, training, audits)
• Experience with electronic Quality Management Systems (e.g., ETQ or similar platforms)
• Experience supporting or participating in internal or external audits preferred
• Technical writing experience, including development or revision of controlled documents (e.g., SOPs, work instructions) preferred
• Experience supporting or participating in internal or external audits preferred

Education

• A bachelor's degree or equivalent experience.
• Licenses/Certificates: Industry Quality Certifications (i.e., ASQ) preferred
• Technology/Equipment: Microsoft Office Applications, eQMS software May 2025

Experience

• Technical writing experience (specifically SOP writing experience)
• Experience with document control or administrative quality processes, including revision control, record management, or document lifecycle activities

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 May 2025