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Quality Assurance Specialist for Medical Software
2 months ago
Position Overview:
The Quality Assurance Specialist will play a crucial role in ensuring that our Software as a Medical Device (SaMD) and Digital Health Software products meet the highest standards of quality and compliance.
Key Responsibilities:
- Lead QA initiatives related to the development of SaMD and Digital Health Software.
- Ensure adherence to software lifecycle policies and quality assurance procedures.
- Conduct design control and risk management activities in line with the Quality Management System.
- Collaborate with technical teams to guarantee that design control documentation and change control requirements are fulfilled.
- Assist in the preparation of documentation for regulatory submissions.
- Identify and address gaps or improvement opportunities within the Design History File and Risk Management processes.
- Take initiative in assignments and actively participate in development and process enhancement teams.
- Monitor the effectiveness of processes and the quality of project deliverables, proposing and implementing improvements as necessary.
- Draft and review policies, processes, and procedures related to the development of SaMD and Digital Health products, ensuring compliance with global regulations.
- Utilize knowledge of international regulations and corporate standards to guide quality assurance efforts.
- Support and prepare for regulatory agency and internal audits.
Qualifications:
- A Bachelor's degree or equivalent in a relevant field such as sciences or engineering is required.
- A minimum of 5 years of experience in Quality Assurance or a related field, with a preference for experience in medical devices, particularly Software Medical Devices.
- In-depth knowledge of regulations and standards applicable to software medical devices, including IEC 62304, 21 CFR, and EU MDR.
- Experience in creating and maintaining Quality Management System documentation for medical device development.
- Proven ability to coordinate complex activities and resolve intricate problems using technical and interpersonal skills.
- Experience in product development, particularly in defining requirements and setting specifications for verification and validation.
- Strong oral and written communication skills, with the ability to clearly articulate quality positions and necessary actions to resolve issues.
- Excellent interpersonal skills, with the ability to lead and negotiate effectively in a team environment.
- Ability to present and justify quality requirements to management clearly.
