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 followup 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 supplier quality activities or 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: - Education: A college 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 Engineerin
What makes Elos Medtech unique?
We empower medical device companies with expert support across product R&D, manufacturing solutions, and a full suite of value-added services—helping them enhance their product offerings while streamlining operations and reducing complexity.
With a commitment to long-term partnerships, our specialized business units bring deep industry expertise, while seamless cross-unit collaboration ensures access to the latest technologies—even those new to a particular field.
Together, we deliver tailored solutions that spark innovation, minimize risk, and drive growth—redefining medical device innovation to enhance lives worldwide.
We put our customers at the heart of everything we do.