Quality Assurance - Administration, training, and auditing of Quality System Tools (Customer Complaints, CAPA, Training, Control Documents, Standards).
- Ensure compliance of quality procedures and work instructions with applicable standards.
- Conduct audits, training, preventive and corrective actions to maintain the QA system.
- Maintain training, qualification, and certification records of personnel.
- Approve/disapprove suppliers, vendors, facilities, equipment, processes, and materials as per Quality Manual.
Regulatory Affairs - Manage regulatory submissions in various countries.
- Provide regulatory support across company functions.
- Define and conduct tests/bench tests for regulatory compliance.
- Review and approve marketing, social media, and labeling materials.
- Report directly to QA Director.
Experience Required: - Hands-on experience in Medical Devices with implementation of QMS.
- Regulatory submissions as per ISO 13485, FDA, CE (MDD/MDR), and MEDDEV.
- Drafting/maintaining SOPs, following GLP/GMP requirements.
- Experience in internal & external audits/inspections.
Preferred Skills: - ERP (Priority) and ALM (Orcanos) systems.
- Strong English communication skills (verbal & written).
- Independent, self-motivated, and proactive working style.
- Strong planning, organizational and interpersonal skills.
- Technical knowledge and adaptability.
Kaapro Management Solutions
