EQMS Manager

eQMS Manager at CAIRE Inc.

The Quality Assurance (QA) eQMS Manager is a key member of the QARA team, responsible for managing the primary functional aspects of the electronic Quality Management System (eQMS). The role ensures compliance with applicable SOPs and supports key quality performance indicators.

• Ensure product/process compliance with the requirements of applicable standards and regulations, including ISO 13485, ISO 9001, FDA QSR, MDD/MDR, PED/TPED, MDSAP, and country‑specific requirements where applicable.
• Directly manage the eQMS functions, including Sys Admin functionalities, Master Control corporate interactions, and document management responsibilities.
• Ensure document control support of change control, CAPAs, nonconformities, and post‑market surveillance, as well as vigilance and continuous improvement efforts.
• Propose and manage continuous improvement implementation of internal quality procedures within the eQMS.
• Support Design and Product Quality colleagues on new product releases and changes to existing products, including labeling and design transfer activities, and any other development activities requiring eQMS support.
• Ensure adequate training and adherence to established SOPs and document control practices related to the eQMS.
• Support maintenance of QA software support programs, ensuring appropriate validations are implemented and maintained.
• Establish, monitor, and report on quality metrics reviewed in monthly Quality Review meetings.
• Support annual Management Review meetings and third‑party external audits.
• Ensure compliance with training programs in the business unit and satellite facilities so personnel are familiar with and knowledgeable regarding applicable processes and requirements.

This position supervises Document Control staff.

This job operates in a professional office environment and manufacturing/distribution environment. The role is expected to be full‑time, either remote or hybrid, preferably at the corporate headquarters and manufacturing facility near Canton, Georgia.

The role is largely sedentary; however, some activity is required. Ability to lift, bend, or stand as necessary is necessary.

This position requires up to 20% travel. Some of the travel may be international.

• Bachelor’s degree from a four‑year college or university, or equivalent work experience.
• 5+ years of medical device experience.
• Experience with various codes and standards, including ISO 13485, FDA QSR, MDR, MDSAP, etc.
• Experience and working knowledge with eQMS programs.
• Good communication skills at all levels (written and verbal).
• Proven ability to work with cross‑functional teams and in a project management environment.
• Demonstrated ability to plan and manage multiple tasks/projects.

• MBA or master’s degree.
• Related certifications commensurate with the role.
• Change management experience.

None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.