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Quality Assurance Specialist for Medical Software
2 months ago
Position Overview:
The role focuses on ensuring quality assurance in the development of Software as a Medical Device (SaMD) and Digital Health Software products. The successful candidate will be integral in executing Quality System requirements to align with global Medical Device Regulations.
Key Responsibilities:
- Lead QA initiatives related to SaMD and Digital Health Software development.
- Guarantee adherence to software lifecycle policies and established procedures.
- Conduct design control and risk management tasks in accordance with the Quality System.
- Collaborate with technical teams to fulfill design control documentation and change control requirements.
- Assist in the preparation of regulatory submission documentation.
- Identify and address gaps or improvement opportunities within the Design History File and Risk Management processes.
- Independently initiate assignments and actively participate in development and process enhancement teams.
- Monitor the effectiveness of processes and quality of project deliverables, proposing and implementing quality improvements.
- Draft and review policies, processes, and procedures related to the development of SaMD and Digital Health products in compliance with international regulations.
- Utilize knowledge of global regulations and corporate standards to guide QA 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.
- Minimum of 5 years of experience in Quality Assurance or a related field, with a preference for experience in Medical Devices.
- Strong knowledge of regulations and standards impacting software medical devices, including IEC 62304 and 21 CFR.
- Experience in developing and maintaining Quality Management System (QMS) documentation.
- Proven ability to coordinate complex activities and resolve intricate problems using technical and interpersonal skills.
- Experience in product development, particularly in defining requirements and specifications for verification and validation.
- Excellent oral and written communication skills to effectively convey quality positions and necessary actions.
- Strong interpersonal skills, capable of managing conflicting priorities and fostering teamwork.
- Ability to present and justify quality requirements clearly to management.
