Senior Quality Engineer

Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work. Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations. Read and interpret technical drawings, procedures, and protocols Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product. Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria. Participates in Customer Complaints investigation for areas under their control. Document investigation findings in analysis report on GCS2 Become a trainer for the Software related with complaints handling process (GCS2), as required. Candidate required process at least Bachelor Degree in any Engineering course, Mathematic, Statistic and Analytic or other Science related course. At least 8 - 10 years of working experience in Quality System regulated organization - ISO 9001/ ISO 13485. Experience in Distribution Quality / Operations Quality / Quality System will be with added advantage. Skill: Excellent Influencing and communication skill, good team player, positive attitude to excel work toward success, problem solving skill and possess leadership dependencies to be able to lead team for issue investigation. Working experience from medical background will be added advantage.