Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. Lead risk management activities to ensure the highest level of product and process quality. Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.**Education / work experience** Minimum of 5 years experience preferred.**Knowledge / competencies** Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation. Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke. Demonstrated ability to read and interpret CAD drawings. Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.Thorough knowledge and understanding of US and International Medical Device Regulations. Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics). Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.Demonstrated ability to advocate for product excellence and quality. Demonstrated ability to effectively work cross(1)functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing. Strong interpersonal skills, written, oral communication and negotiations skills.Highly developed problem solving skills.Strong analytical skills. Demonstrated ability to successfully manage and complete projects in a matrix organization. Demonstrated ability to work independently. Experience in working in a compliance risk situation. Computer literacy (including proficiency with Mini-Tab or similar analysis program).
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