Deskripsi Pekerjaan
Join a global leader in medical technology as a Quality Assurance Engineer (Customer Feedback Handling) at Terumo. We are looking for a meticulous and proactive professional to ensure the integrity of our products and the safety of our patients. In this key role, you will be responsible for managing the entire lifecycle of customer complaints and adverse events, ensuring they are resolved efficiently and in compliance with regulatory standards.
Working out of our state-of-the-art facility in Laguna Technopark, you will play a vital part in our quality management system. You will collaborate with cross-functional teams to drive continuous improvement, analyze trends, and implement effective corrective actions. If you are driven by a passion for quality and want to make a meaningful impact in the healthcare industry, this is an excellent opportunity to advance your career.
Tanggung Jawab
- Monitor, log, and track all incoming customer complaints and adverse events within the Quality Management System (QMS).
- Conduct in-depth investigations to identify the root cause of product failures or service issues.
- Develop and implement Corrective and Preventive Actions (CAPA) in collaboration with R&D and Manufacturing.
- Ensure strict compliance with regulatory requirements, including FDA, ISO 13485, and other applicable medical device regulations.
- Prepare comprehensive reports and documentation for management review and regulatory audits.
- Liaise with external customers and internal stakeholders to ensure clear communication and timely resolution of issues.
- Participate in quality improvement initiatives and internal process audits to enhance operational efficiency.
Kualifikasi
- Bachelor’s degree in Engineering (Mechanical, Chemical, Bio-medical), Quality Assurance, or a related field.
- Proven experience in Quality Assurance, Customer Support, or Complaint Handling, preferably within the Medical Device or Manufacturing sector.
- Familiarity with regulatory frameworks such as ISO 13485, FDA 21 CFR Part 820, and MDR is highly preferred.
- Strong analytical skills with the ability to interpret data and identify systemic issues.
- Excellent written and verbal communication skills for effective reporting and stakeholder engagement.
- Proficiency in using QMS software (e.g., MasterControl, IQMS) and Microsoft Office Suite.
- Ability to work effectively under pressure and meet strict deadlines in a fast-paced environment.