- Professional
- Ufficio in Diepenbeek
The Quality Management System (QMS) Engineer is responsible for the document management, maintenance, compliance reporting, internal auditing, training, and continuous improvement of the Quality Management System (QMS) to support compliance with ISO 13485, FDA 21 CFR Part 820, and MDR 2017/745.
Key Responsibilities
QMS Maintenance & Compliance Reporting
- Maintain and update the QMS documentation to ensure ongoing compliance with ISO 13485, FDA 21 CFR 820, and MDR 2017/745.
- Ensure regulatory compliance reporting and timely submission of quality reports.
- Monitor quality metrics and generate compliance reports for management review and Maintain Quality performance dashboard.
- Assist in CAPA (Corrective and Preventive Action) management and follow-up.
Internal Audits & Quality System Monitoring
- Conduct internal audits to assess compliance with regulatory requirements and company policies.
- Support audit preparation, execution, and follow-up for Notified Body and FDA inspections.
- Work with cross-functional teams to address audit findings and implement corrective actions.
Training & Awareness
- Develop and deliver QMS training programs for employees to ensure awareness and adherence to quality policies and procedures.
- Maintain training records and ensure personnel are up to date on quality requirements.
- Support new employee onboarding with QMS-related training.
Supplier and Vendor Compliance Monitoring
- Assist in supplier audits, risk assessments, and performance evaluations. - Monitor and update the approved supplier list and quality agreements.
Complaint Handling
- Support complaint handling and investigations.
- Support Post-Market Surveillance (PMS) activities.
- Assist in CAPA implementation related to post-market feedback.
Continuous Improvement
- Participate in continuous quality improvement initiatives, including Lean, Six Sigma, and other methodologies.
- Monitor and recommend improvements to existing quality processes to enhance efficiency and compliance.
- Act as a CAPA owner for QMS improvement initiatives.
Document control
-Responsible for administration of documented information, SOPs and records
- Maintain and update the QMS documentation to ensure ongoing compliance with ISO 13485, FDA 21 CFR 820, and MDR 2017/745.
- Ensure regulatory compliance reporting and timely submission of quality reports.
- Monitor quality metrics and generate compliance reports for management review and Maintain Quality performance dashboard.
- Assist in CAPA (Corrective and Preventive Action) management and follow-up.
Internal Audits & Quality System Monitoring
- Conduct internal audits to assess compliance with regulatory requirements and company policies.
- Support audit preparation, execution, and follow-up for Notified Body and FDA inspections.
- Work with cross-functional teams to address audit findings and implement corrective actions.
Training & Awareness
- Develop and deliver QMS training programs for employees to ensure awareness and adherence to quality policies and procedures.
- Maintain training records and ensure personnel are up to date on quality requirements.
- Support new employee onboarding with QMS-related training.
Supplier and Vendor Compliance Monitoring
- Assist in supplier audits, risk assessments, and performance evaluations. - Monitor and update the approved supplier list and quality agreements.
Complaint Handling
- Support complaint handling and investigations.
- Support Post-Market Surveillance (PMS) activities.
- Assist in CAPA implementation related to post-market feedback.
Continuous Improvement
- Participate in continuous quality improvement initiatives, including Lean, Six Sigma, and other methodologies.
- Monitor and recommend improvements to existing quality processes to enhance efficiency and compliance.
- Act as a CAPA owner for QMS improvement initiatives.
Document control
-Responsible for administration of documented information, SOPs and records
Why work at invoX?
We get things done, we keep things simple and we are driven by the science. We are ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations and socialising, which make invoX a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.
