Quality Assurance Coordinator Position Description: We are seeking a Quality Assurance Coordinator to ensure that all products and services comply with the company's quality standards. * **Education:** Bachelor’s degree in Engineering, Biomedicine, Pharmacy, or related fields. **Requirements:** + Advanced English proficiency. + Solid experience in **Quality Assurance** and **regulatory compliance** within the medical device industry. + Proficient in **ISO 13485**, **Good Manufacturing Practices (GMP)**, and other applicable regulations. + Strong **leadership**, **organizational**, and **communication** skills for coordinating multidisciplinary teams. + Analytical mindset and strong **decision-making** ability in regulated environments.**Preferred Qualifications:** + Certifications in Quality Management (e.g., **Lead Auditor ISO 13485**, **MDR Auditor, ISO 17025 Auditor**). + Experience with **root cause analysis and risk management tools** (e.g., **FMEA**, **FTA**). + Familiarity with **quality management software** (e.g., **SE Suite**).**Key Responsibilities:** + Coordinate **Quality Assurance** processes, ensuring compliance with regulatory requirements, **GMP**, **ISO 13485:2016**, and other applicable standards. + Ensure products are manufactured according to internal specifications and standards required by regulatory authorities. + Conduct **internal audits** and plan/oversee **external audits** (ANVISA, FDA, CE, and others). + **Manage non-conformances and corrective and preventive actions** (CAPA), conducting root cause investigations, defining corrective and preventive actions, and monitoring their implementation. + **Monitor customer complaints** and coordinate action plans for resolution. + Ensure the **integrity, traceability, and control of technical and quality documentation**, including manufacturing records, specifications, and test reports. + Coordinate and deliver **training** on quality practices, applicable regulations, and process updates, ensuring team alignment with company policies and procedures. Collaborate with **Operations** teams to resolve issues and **implement continuous process improvements**