Deskripsi pekerjaan
Job Description Manage Complaint Handling processes and customer complaint investigations. Manage the Corrective and Preventive Action (CAPA) system and monitor its effectiveness. Prepare periodic Post-Market Surveillance (PMS) trend analyses and reports for Management Review. Manage and monitor the calibration program for measuring and monitoring equipment. Ensure calibration records are maintained, and equipment calibration status remains valid. Support the execution of Internal Audits, Customer Audits, and External Audits. Monitor the closure of audit findings, customer complaints, and CAPA actions. Support Product Recall activities in accordance with established procedures and applicable regulatory requirements. Ensure compliance with ISO 13485, applicable regulatory requirements, and company quality procedures. Job Qualifications Minimum Bachelor's Degree (S1) in Science, Engineering, or other relevant disciplines. Fresh graduates are welcome to apply; candidates with experience in Quality Assurance, Production, or Quality Control within the Pharmaceutical or Medical Device Industry are preferred. Possess basic knowledge of Good Manufacturing Practices for Medical Devices (CPAKB), Halal Assurance System (SJH), and EN ISO 13485 requirements. Candidates with knowledge of US FDA regulations and EU MDR requirements for medical devices will be at an advantage.
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Gaji
- Negosiasi
- Batas lamaran
- 04 Agustus 2026