The Senior Quality Compliance Specialist/Lead Auditor is responsible for ensuring all Corrective Action/Preventive Action (CAPA) and Internal Audit activities are compliant to ZOLL’s Quality Management System (QMS). This individual will be responsible to identify, analyze, investigate, monitor, and document patterns and trends in post market surveillance data as part of the CAPA and Internal Audit systems. Communicate to Management, QA, R&D, Operations and other departments regarding product performance, quality compliance and system metrics.
Ability to read, analyze and interpret complex quality documents.
Ability to apply and understand advanced mathematical operations.
Ability to problem solve.
Working knowledge of desktop computer and software programs.
Certificates and Licenses:
Auditor certification required.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.
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.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is also required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus.