This position is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.
Bachelor’s Degree or a minimum of 4 years of work experience.
Minimum of 1-year experience working in a regulated industry or a Masters degree.
Minimum of 3 years experience in a regulated industry is preferred
Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
Demonstrated knowledge of strong P&PC requirements, Quality Management System tools, continuous improvement methodologies & in-depth understanding of site-level products & related processes
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