Quality Engineer
2 months ago
Job Summary:
We are looking for an experienced medical device Design Quality Engineer to ensure that our software products meet the highest standards of quality and regulatory compliance. The ideal candidate will have a strong background in medical device regulations, risk management and preferably in in software quality assurance.
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.
Tell employers what skills you have
Regulatory Compliance
Analytical Skills
Quality Management
Quality Assurance
Software Quality Assurance
Regulatory Affairs
ISO
Artificial Intelligence
Software Engineering
Medical Devices
Artificial Intelligence Application
Visualization
Product Development
Regulatory Requirements
Data Analytics
Regulatory Submissions
Software Development
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