Quality Engineer

2 weeks ago


Singapore GOODTECH PTE. LTD. Full time

**Job Summary**:
**Key Responsibilities**:

- Support QMS consultant on Develop and implement quality assurance processes and procedures for SaMD products.
- Conduct thorough reviews of software design and development documentation to ensure compliance with regulatory standards and company policies.
- Perform software risk management activities, including hazard analysis and risk assessments.
- Ensure all software development activities comply with relevant medical device regulations (e.g., IEC 62304, ISO 13485, FDA guidelines).
- Prepare and review documentation required for regulatory submissions and audits.
- Support internal and external audits, addressing any findings related to software quality and compliance.
- Support HSA regulatory submission activities

**Qualifications**:

- Bachelor’s or master’s degree in computer science, Software Engineering, Biomedical Engineering, or a related field.
- Minimum of 2 years of experience in the medical device industry, preferably in Software as medical devices.
- Experience with regulatory compliance for medical devices
- Familiarity with software validation and verification processes.
- Excellent problem-solving skills and attention to detail.
- Strong communication and teamwork abilities.



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