Job Description

How Will You Make an Impact? Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com. What will you do?

• Retrieve complaints from various database and update complaint log.
• Initiate due diligence attempts to obtain complaint information and MDR (Medical Device Reporting) checklist based on risk assessment criteria.
• Process complaints by classifying them based on failure mode in a uniform and timely manner.
• Provide Product Quality Engineer with quality data and trends in product performance in meeting customer requirements.
• Follow up on RMA (Return Material Authorization) status.
• Support Product Quality Engineer to establish DMRI (Device Master Record Index)
• Support Product Quality Engineer to draft COO (Country of Origin), COA(Certificate of Analysis), COC(Certificate of Conformance)
• Support Product Quality Engineer to manage inter-company purchased raw material.
• Support Customer samples (Demo Units) and Engineering Samples (Testing units) build for new products/transfer product.
• Work with cross functional team on resolution of product, package quality and reliability issues during the NPI process/ Transfer products.
• Work with Product Quality Engineer and Cross Functional team to execute NPI/ transfer of pilot products and packages based on the New Products roadmap.
• Participate in quality initiatives program to address system inadequacies which may include quality programs, tracking, analyzing, reporting and problem solving to achieve continual quality improvement objectives.
• Supports company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA regulations.
• Ensure that procedures are in compliance with ISO9001, ISO14001, ISO13485, ISO14971 and FDA 21CFR Part 820 requirement.
• Support plant-wide activities and special projects, as assigned.

• Diploma in Engineering (Mechanical or Electronics) or Diploma in Science (Biology, Chemistry, Bioengineering.)

• Knowledge of statistical controls and data analysis
• Knowledge of using ERP systems: SAP
• Knowledge of using QMS Software: Trackwise
• Knowledge of using CRM Software: SalesForce
• Proactive and assertive attitude
• Willingness to be highly visible and accountable
• Ability to interface effectively with many internal and external groups
• Good communication skill Well organized and capable of self-management of projects
• High degree of computer literacy