Quality Control Engineer

HOYA Technosurgical, a subsidiary of HOYA Corporation, established in Tokyo, Japan in 2013, has its origins in the PENTAX medical business unit from 1974, following the merger of the former PENTAX medical business unit and Japan Universal Technologies, Inc. HOYA Technosurgical has set up its first overseas plant in Singapore, focusing on the manufacturing, research & development, and sale of Chromatography Media to pharmaceutical companies. Main Purpose of Job: This new position is responsible for performing production-related inspection jobs, carrying out equipment and calibration, and maintaining documentation and records. Key Duties & Responsibilities: Prepare the lab for ISO 9001:2015 certification audits, including laboratory equipment qualification and method validation. Responsible for manufacturing management and quality control (QC) based on the quality assurance system (QAS). Design and develop forms, work instructions, and methods for testing and evaluation. Utilize knowledge in engineering fields for chemical and product quality inspection. Ensure lab equipment/instrument calibration and maintenance are maintained as planned. Trend and feedback of monitoring data to relevant sections and drive for investigation and action as necessary. Chemical analysis of products using ICP, X-ray diffractometer, HPLC, FTIR, particle size analyser, UV, endotoxin test, and chloride, sulfate, carbonate limit test. Carry out TOC, endotoxin test, and environmental monitoring tests. Carry out maintenance and calibration of equipment. Maintain accurate inspection, maintenance, and calibration records. Perform investigation when the test results are out-of-spec or abnormal. Prepare validation documents and carry out the qualification of equipment. Cross-functional collaboration to achieve compliance with quality requirements, improvements, development and implementation of new products/processes, and supporting customer complaints. Process explanation and audit support in customer audits. Corrective and preventive action (CAPA) support. Perform all other duties assigned by the supervisor or manager. Education: Diploma in a scientific discipline or possess equivalent experience or higher. Experience: Five years’ experience in a medical device or pharmaceutical laboratory environment. Experience with lab equipment such as HPLC, ICP, FT-IR, UV Spectrometer, and environmental monitoring sample testing. Familiar with ISO 9001:2015 requirements. Proficient in Microsoft Word and Excel. Working Conditions: Work is generally performed within an indoor laboratory environment with adequate temperature. Personal protective equipment (PPE), such as a laboratory coat, safety shoes, appropriate gloves, hearing protection, and respiratory protection, will be required for potential exposure to hazardous chemicals and noise hazards. #J-18808-Ljbffr