Quality Assurance eQMS Manager

The Quality Assurance (QA) eQMS Manager is a key member of the QARA team, responsible to manage primary functional aspects of the electronic Quality Management System (eQMS), ensuring compliance with applicable SOPs.

The QA eQMS Manager will work with Design Quality, Product Quality, and cross-functional staff to effectively implement continuous improvements, monitor key quality performance indicators, and meet established goals.

The QMS covers domestic locations in Georgia and New York, as well as a manufacturing site in Chengdu, China, and Service & Repair centers in the US and EU (Langenfeld, Germany and Padova, Italy). This manager will also provide mentoring, leadership, and development of any direct reports.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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 SysAdmin functionalities, MasterControl corporate interactions, and Document management roles and 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, as well as 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 3rd party external audits.
• Ensure compliance to training programs in the business unit and satellite facilities to ensure personnel are familiar with and knowledgeable regarding applicable processes and requirements.

Supervisory Responsibility

This position supervises Document Control staff.

Work Environment

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, located near Canton, Georgia.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This is largely a sedentary role; however, some activity is required. This would require the ability to lift, bend or stand as necessary.

Travel

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

Required Education and Experience

• Bachelor’s degree from a four-year college or university, or equivalent work experience
• 5 years of medical device experience required
• Experience with various Codes and Standards (ISO 13485, FDA QSR, MDR, MDSAP, etc.) required
• 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

Preferred Education and Experience

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

Additional Eligibility Qualifications

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.