Responsibilities :
- Oversee the daily quality activities including involvement in new project development with relate to technical and non-technical operations
- Resolves customer inquiries, quality, and operational issues in a timely manner by consulting with the Business Development HOD, Operation Manager, QA Manager, other supporting managers, Superior
- Manage, lead, and motivate a team of quality inspectors and technicians to meet departmental objectives and goals, create and promote food safety, GDP, GMP & lead by example
- Involved in new product and project development to establish internal specification and keep abreast of customer requirements
- Document in STL’s quality system and implement programs to ensure compliance with applicable regulatory requirements and corporate’s quality system requirements
- Develop and continually improve production, inspection and process control activities, corrective & preventive action, hazard analysis and risk management
- Responsible for timely closure of CAPA, non-conformance investigation report, customer complaints and deviations. Escalate to superior if required
- Analyse and trend various Key Performance Indicators per management’s vision and direction, including indicator of interest
- Develop, reviews, and approves qualifications and validation protocols, involvement in food Hazard / Medical device Risk management activities and departmental level risk and opportunity assessment, including JSA
- Ensures effective communication internally & externally
- Ensure department’s personnel competency, develop, and retain skill base knowledge within the organisation, through training needs identification
- Take reasonable care of workplace health and safety; abide by all EHS policies and procedures; cooperate with Management and colleagues in EHS initiatives
Requirements :
Minimum Diploma / Degree in Biomedical / Mechanical Engineering or equivalentMinimum 0 – 4 years of relevant experience in a dynamic medical Device manufacturing environmentPossess knowledge of Quality tools and Quality concept fundamentalsAble to perform root cause analysis, process optimization, data analysis and validation effectively manage a high-volume manufacturing setting / environmentAbility to apply problem solving technique and provide solutions under minimal supervisionGood written and oral communication skillsThe above statements reflect the general tasks, duties, activities and / or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties / responsibilities may change or vary in response to business needs.