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Quality Assurance Auditor


This is a Full-time position in Dover, DE posted April 2, 2021.

nn Overview: nn nnTo perform quality audits and assessments of ERT’s procedures and data to assure compliance and quality of the services and systems developed and implemented by ERT.

nn nn nn nn Please note this position deals with documentation and data QA rather than Laboratory-related QA.

nn nn  nn nn ESSENTIAL DUTIES AND RESPONSIBILITIES: nn Perform internal audits and gap analyses of ERT’s operational and technical departments and processes to ensure compliance with ERT SOPs, Good Clinical Practices, and EN ISO 9001/ISO 13485 and applicable regulatory requirements.

This includes all processes related to ERT’s System Development Life Cycle.

Perform audits of ERT’s vendors to assess their Quality Management System, and their ability to meet ERT contractual agreements, ERT quality standards, and applicable regulations.

Assist with the hosting and management of client audits.

Analyze any observations identified and work with applicable departments to generate effective corrective and preventive action responses.

Develop auditing plans and compile reports for assigned audits.

Manage corrective action and preventive action responses received for internal and vendor audits, and responses defined for external audit observations.

Conduct follow-up with the applicable departments to ensure timelines for corrective actions are met.

Perform tracking/trending analysis of audit findings.

Perform quality reviews of key documents defined by ERT’s System Development Life Cycle specifically related to: Medical Device Development/Change Control System Requirements Testing/Validation Records Installation Qualification System Maintenance Records Migration Records Perform quality reviews to ensure the data and processes implemented by ERT are compliant with applicable regulations, guidelines, and internal procedures.

This includes quality reviews of primary study documentation including raw data, reports, data listings, and FDA XML file deliverables as well as the establishment and training of ECG measurement criteria and alert ranges.

Conduct ongoing internal meetings to monitor internal quality programs and issues.

nn OTHER DUTIES AND RESPONSIBILITIES: nn nn nn Author Quality Assurance/Regulatory Affairs standard operating procedures as required.

Provide Annual Quality Assurance/Regulatory Affairs Training Courses to ERT staff, as necessary.

Provide consulting services to contracted external sources as required.

Assist in the development or execution of system testing as required.

Participation in this task may only occur if the Quality Assurance Auditor is not assigned to the project in an audit role.

nn nn nn The duties and responsibilities listed in this job description represent the major responsibilities of the position.

Other duties and responsibilities may be assigned, as required.

This job description and any attachments do not constitute or represent a contract.