Senior Design QA Engineer - Compliance & Risk Lead

West Pharmaceutical Services, Inc; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A global healthcare company in Singapore is seeking a Senior Design Quality Assurance Engineer to lead compliance in proprietary design and regulatory projects. This role requires 5-7 years of experience in a regulated environment and a degree in Chemistry or Engineering. Key responsibilities include managing quality aspects of projects and facilitating risk assessments. The ideal candidate will possess a strong background in ISO standards and provide design assurance support, promoting a culture of quality and continuous improvement.

Qualifications

• 5 to 7 years working in a high-volume regulated manufacturing environment.
• Desirable: Regulatory Affairs experience.

Responsibilities

• Ensure compliance of design & development projects with regulations and standards.
• Support quality practices during design control activities.
• Report on project progress and identify successes.
• Review and approve design history files and product documentation.
• Facilitate risk assessment meetings.

Skills

Practical experience with design teams

Working knowledge of ISO 13485

Experience in process technology

Risk Management experience

Understanding of rubber and plastic manufacturing technologies

Knowledge of analytical tools and methods

Education

Degree in Chemistry, Engineering or Quality discipline

Tools

Minitab

Job description

A global healthcare company in Singapore is seeking a Senior Design Quality Assurance Engineer to lead compliance in proprietary design and regulatory projects. This role requires 5-7 years of experience in a regulated environment and a degree in Chemistry or Engineering. Key responsibilities include managing quality aspects of projects and facilitating risk assessments. The ideal candidate will possess a strong background in ISO standards and provide design assurance support, promoting a culture of quality and continuous improvement.