Quality Control Engineer

5 days ago


Singapore HOYA TECHNOSURGICAL CORPORATION Singapore Branch Full time
Roles & Responsibilities

HOYA Technosurgical, is a subsidiary of HOYA Corporation, established in Tokyo, Japan in 2013, which has the origin of PENTAX medical business unit in 1974 arising from the merger of former PENTAX medical business unit & Japan Universal Technologies, Inc. HOYA Technosurgical has setup their first overseas plant in Singapore focusing on manufacturing, research & development and sale of Chromatography Media to pharmaceutical companies.

Main Purpose of Job:

This replacement position is responsible for ensuring the quality and consistency of manufactured final products. The individual will be tasked with executing quality control tests, analyzing data, and implementing quality improvement initiatives. Additionally, they will perform production-related inspections, carry out equipment calibrations, and maintain documentation and records.

Key Duties & Responsibilities:

· · 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

· Utilising 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 of records.

· Perform investigation when the test is out-of-spec or atypical.

· Prepare validation documents and carry out the qualification of equipment, software, etc.

· Cross-function collaboration to achieve compliance with quality requirements, improvements, development and implementation of new products /processes, supporting customer complaints, etc.

· Process explanation and audit support in customer audit

· Corrective and preventive action (CAPA) support

· Perform all other duties assigned by the supervisor or manager

Education:

· Bachelor's degree in Chemistry, Biochemistry, or a related field.

Experience:

· Five years experience in a medical device or pharmaceutical laboratory environment

· Statistical Process Control (SPC) and statistical knowledge are a must.

· Excellent data analysis and problem-solving skills.

· Have working 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 at an adequate temperature. Personal protective equipment (PPE), such as a Laboratory coat, Safety shoes, Appropriate gloves, hearing protection, Respiratory Protection, etc., will be required for potential exposure to hazardous chemicals and noise hazards.

Tell employers what skills you have

FTIR
Quality Control
Quality Assurance
HPLC
ISO
Investigation
Quality Inspection
Equipment Qualification
Audits
Microsoft Word
UV
Laboratory
Manufacturing
Audit
Calibration

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