Quality Assurance Officers

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.

If you are ready to give your best and join an environment that values collaboration and commitment, we look forward to receiving your application.

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., The position provides foundational support across QMS elements including document control, change management, and supplier quality activities.

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

Ensure controlled documents and records are maintained in compliance with internal procedures and regulatory requirements

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

Work cross-functionally to ensure timely completion of document updates, reviews, and approvals

Assist in internal and external audit preparation by providing document and system support Additional functions may be added at discretion of Management Skills

Attention to detail with a focus on documentation accuracy, completeness, and data integrity

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

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 supplier quality activities or audits preferred

Technical writing experience, including development or revision of controlled documents (e.g., A bachelor's degree or equivalent experience.

Industry Quality Certifications (i.e., Technology/Equipment: Microsoft Office Applications, eQMS software May 2025

Technical writing experience (specifically SOP writing experience)

Experience with document control or administrative quality processes, including revision control, record management, or document lifecycle activities

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

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

Exposure to various manufacturing environments, including controlled or regulated areas, in accordance with site safety and compliance requirements

Reporting Structure