QA Engineer

Sunningdale Tech Ltd; Singapore; On-site; SGD 40,000 - 60,000; Full time

Job summary

A leading manufacturing company in Singapore is seeking an individual with a Diploma/Degree in Biomedical or Mechanical Engineering to oversee daily quality activities and manage a team of quality inspectors. The ideal candidate will have 0-4 years of experience in a medical device manufacturing environment. Effective communication skills and knowledge of quality tools are required. This role emphasizes compliance with regulatory requirements and effective team leadership.

Qualifications

• Minimum 0 – 4 years of relevant experience in a dynamic medical device manufacturing environment.
• Able to effectively manage a high-volume manufacturing setting/environment.

Responsibilities

• Oversee daily quality activities and involvement in new project development.
• Resolve customer inquiries and operational issues in a timely manner.
• Manage and lead a team of quality inspectors and technicians.

Skills

Knowledge of Quality tools and concepts

Root cause analysis

Process optimization

Data analysis

Good communication skills

Education

Diploma / Degree in Biomedical / Mechanical Engineering

Job description

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 equivalent
• Minimum 0 – 4 years of relevant experience in a dynamic medical Device manufacturing environment
• Possess knowledge of Quality tools and Quality concept fundamentals
• Able to perform root cause analysis, process optimization, data analysis and validation effectively manage a high-volume manufacturing setting/environment
• Ability to apply problem solving technique and provide solutions under minimal supervision
• Good written and oral communication skills

The 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.