Quality Assurance Specialist

Summary/Objective

The QA/RA Specialist is key member of the Quality Assurance and Regulatory Affairs team to ensure continued regulatory compliance for all products. This position will work with cross-functional teams and product design to ensure products continue to meet state of the art regulatory compliance and are labeled correctly. The Specialist will coordinate with the Quality Dept. to ensure compliance to the QMS functions and risk files.

This position will be based onsite at our Ball Ground, GA headquarters, which is approximately 30 miles north of the greater Atlanta, GA area.

Essential Functions

• Ensure product/process compliance with the requirements of ISO 13485, FDA QSR, MDD, TPED, MDSAP, etc. through review and approval Engineering Change Orders for compliance with Design Control Requirements.
• Coordinate and manage the CAPA program by tracking CAPAs through MasterControl and holding meetings as needed to ensure appropriate root cause and corrective actions are applied. Improve CAPA processing time.
• Customer complaint quality review, processing and closure including reports to customer as needed.
• Assist with audit support for 3rd party, notified body and regulatory authority audits. Participate on the internal audit team as needed.
• Perform routine supplier audits to maintain compliance for critical suppliers as reported to the notified body. Generate audit schedule and plan trips efficiently to control costs.
• Manage software programs to ensure that upgrades and new revisions are appropriately validated. Assist with software validation process and the MyCAIRE application.
• Participate in Regulatory Team meetings assuming additional projects and tasks as required.

Competencies

• Good business ethics
• Communication Proficiency
• Presentation Skills
• Collaboration
• Teamwork Orientation
• Project Management
• Technical Capacity

Work Environment

This job operates in a professional office environment and manufacturing/ distribution environment.

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 15% travel. Some of the travel may be international.

Required Education and Experience

• Bachelor’s degree in from a four-year college or university, preferably an engineering or technical degree
• 3 years of related experience required
• Experience with various Codes and Standards (ISO 13485, FDA QSR MDD, MDSAP, etc.) required
• Working knowledge of EU MDR (2017/745)
• 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.
• Experience with U.S. FDA 510(k) submittals
• Experience and working knowledge with software product approvals.

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.

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

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.