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Job Description
Medical Device Quality Assurance Specialist: Ensure product development and maintenance compliance with FDA, ISO, and EU regulations by designing control plans, conducting risk management, and supervising internal and supplier audits. Collaborate with cross-functional teams and lead personnel in support of business needs. Bachelor degree in science, engineering, or equivalent with 8+ years of industry experience required. Experience in design quality assurance, risk management, and lead auditor certification beneficial. Competence in statistical tools and understanding of human factors, user-interface design, and subsystem technologies also required. Knowledge of medical device regulations, including FDA, GMP, and ISO 13485, essential.