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 set up their first overseas plant in Singapore focusing on manufacturing, research & development and sale of Chromatography Media to pharmaceutical companies.

Reporting Relationship:

Direct reporting line to the Manager, Quality

Main Purpose of Job:

Responsible for ensuring a product meets the established quality standards, including reliability, usability and performance required for distribution and the market.

Key Duties & Responsibilities:

• During the plant set-up phase:
• Document control - Review and archive qualification documents from production and QC.
• Manage organisation-wide quality-related training requirements and standardsQA operations support - Support production document review and participation in installation qualification walkdown.
• Support QC equipment qualification
• Vendor qualification/ supplier management

During routine operations:

• Review and release raw materials, intermediate products and finished products.
• Draft quality assurance policies and procedures
• Manage the QMS works in QMS software.
• Supplier management, such as performing supplier audits, supplier assessments, etc.
• Interpret and implement quality assurance standards and procedures.
• Evaluate the adequacy of quality assurance standards.
• Devise sampling procedures and directions for recording and reporting quality data.
• Review the implementation and efficiency of quality and inspection systems.
• Document internal audits and other quality assurance activities.
• Investigate customer complaints and non-conformance issues.
• Collect and compile statistical quality data.
• Analyze data to identify areas for improvement in the quality system.
• Develop, recommend, and monitor corrective and preventive actions.
• Identify training needs and organise training interventions to meet quality standards.
• Coordinate and support on-site audits conducted by external providers.
• Monitor risk management activities.
• Responsible for document management systems.
• Prepare monthly quality metrics.
• Perform all other duties assigned by the supervisor or manager.

Education:

Bachelor's degree in a scientific discipline or equivalent experience or higher.

Skills:

• Attention to detail
• Execellent written and verbal communication skills
• Excellent inter-personal skills
• Empathic problem-solving
• Ability to work effectively and collaboratively across functions

Experience:

• Four to six years of experiencein the ISO manufacturing environment or medical device or pharmaceutical industry
• Quality inspection, auditing and testing experience
• Knowledge of tools, concepts and methodologies of QA, e.g., root cause analysis, flow chart and histogram
• Familiar with ISO 9001:2015 requirements
• Proficient in Microsoft Word and Excel

Travel Requirement:

Ad hoc for training in Singapore and/or Japan, if any

Working Conditions:

Work is generally performed within an indoor laboratory and production environment with 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.