Job Responsibilities:

• Retrieve complaints from various database and update masterlist.
• Accurately review, assess and process complaints in a uniform and timely manner.
• Initial due diligence attempts to obtain complaint information and MDR checklist based on risk assessment criteria.
• Review of technical complaint threshold report with complaint and perform escalated complaint(s) from various database into Trackwise System.
• Participate in the development and implementation of quality initiatives to address system inadequacies as well as to achieve continual quality improvement objectives.
• Support and carry out quality initiatives program to address system inadequacies this may include quality programs, tracking, analyzing, reporting and problem solving.
• Supports company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA regulations.
• Provide management with quality data and trends in product performance in meeting customer requirements by providing and monitoring of:
  • Product quality trend and address product issues.
  • Work with cross functional in evaluation and qualification of material and processes.
• Ensure that systems and procedures are in compliance with ISO9001, ISO14001, ISO13485, ISO14971, FDA 21CFR Part 820 and OHSAS 18001 requirement.
• Participate in quality escalation issues.
• Support plant-wide activities and special projects, as assigned.

Job Requirements:

• Degree in Engineering, with preferably 1-2 years of relevant working experiences.
• Diploma in Engineering with at least 3-5 years of relevant working experiences.