What are the responsibilities and job description for the QA Agent position at HealthLink Europe?
QA Agent
- Location: Memphis
Managed quality administration
Processing, checking, monitoring and handling administrative quality management activities (document control and change requests) and processing them in quality management system;
Managing and maintaining documents, work instructions and procedures in accordance with applicable quality standards;
(on behalf of a manager) drawing up documents, work instructions and procedures in accordance with applicable quality standards;
Maintaining and monitoring quality instruments and standards;
Monitoring of CAPAs (corrective and preventive actions) and Complaints and identifies deviations and escalates if necessary.
Coordinating and carrying out (physical) quality controls, internal audits and supporting external audits
Following up and checking rework activities at the customer's request
Supporting local QA specialist(s)
Managing and maintaining documents, work instructions and procedures in accordance with applicable quality standards;
(on behalf of a manager) drawing up documents, work instructions and procedures in accordance with applicable quality standards;
Maintaining and monitoring quality instruments and standards;
Monitoring of CAPAs (corrective and preventive actions) and Complaints and identifies deviations and escalates if necessary.
Coordinating and carrying out (physical) quality controls, internal audits and supporting external audits
Following up and checking rework activities at the customer's request
Supporting local QA specialist(s)
Support provided
Serves as 1st point of contact for handling or resolving QA questions (support function);
Handling, providing information and advising on various QA issues in the field of WMS system, internal communication platform and procedures and work instructions in QMS;
Maintaining contact about QA issues with internal employees, managers and external stakeholders (i.e. customer contacts);
Supporting Quality department/colleagues with various quality tasks
Supporting employees in the use of quality management systems and procedures;
Support in obtaining the necessary certifications and hosting customer audits in the field of quality management systems.
Handling, providing information and advising on various QA issues in the field of WMS system, internal communication platform and procedures and work instructions in QMS;
Maintaining contact about QA issues with internal employees, managers and external stakeholders (i.e. customer contacts);
Supporting Quality department/colleagues with various quality tasks
Supporting employees in the use of quality management systems and procedures;
Support in obtaining the necessary certifications and hosting customer audits in the field of quality management systems.
Optimized quality management system
Identifying bottlenecks and opportunities for improvement, making improvement proposals to managers;
Identifying improvements in quality processes, procedures and
Instructions
Conducting Internal process audits related to risk factors and department/Management/Manager requests.
Participating in internal working groups and improvement projects, providing input from the field;
Providing input for documents, work instructions and standards.
Identifying improvements in quality processes, procedures and
Instructions
Conducting Internal process audits related to risk factors and department/Management/Manager requests.
Participating in internal working groups and improvement projects, providing input from the field;
Providing input for documents, work instructions and standards.
Prepared reports
Registering, communicating and reporting on incidents;
Investigating Root Causes and proposing Corrective Actions;
Report on the progress of actions to be carried out;
Delivering reports on request.
Investigating Root Causes and proposing Corrective Actions;
Report on the progress of actions to be carried out;
Delivering reports on request.
Complies with laws, regulations and procedures
Compliance with legal requirements and business obligations.
Ensure compliance with quality procedures including ISO 13485, FDA, and other agencies.
Ensure compliance with quality procedures including ISO 13485, FDA, and other agencies.
Job requirements
Education, knowledge and experience:
- Associates Degree-suggested, Bachelor’s Degree a plus.
- Experience with administrative and logistical processes;
- Knowledge of quality management, ISO 13485 and/or 9001, Medical Device quality & regulatory affairs, FDA compliance
- Documented experience conducting audits, Lead Auditor Certification a plus.
- Minimum of 3 years of experience in Quality Assurance
Competences and skills:
- Excellent verbal and written skills in English, a second language is preferred
- Microsoft Office knowledge (Word, Excel, PowerPoint and Outlook, preferably Visio)
- Strong communication, analytical and presentation skills
- Customer-oriented (internal/external) and is able to create connection and collaboration within team and other departments
Additional information/requirements
In addition to the main responsibilities and requirements described above, the employee is expected to:
- Possess flexible working hours
