What are the responsibilities and job description for the Device Quality Systems Specialist position at True Digital Surgery?
Required Skills and Qualifications
- Quality Management Experience: Minimum 4 years of related experience in the medical device industry or equivalent combination of education and experience.
- Technical Knowledge: Expert knowledge of ISO 13485, 21CFR820, EU Medical Device Regulation (MDR 2017/745), and medical device classification (Class II, IIa, IIb).
- Communication Skills: Excellent written and verbal communication skills, with the ability to lead project teams and communicate with external partners and stakeholders.
- Computer Skills: Proficiency in Microsoft Office and database software, with knowledge of e-filing for US FDA applications for medical devices.
