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.
