【武汉外资医疗器械耗材质量经理招聘】-猎头顾问武汉招聘信息-猎聘

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资深顾问(SC) · 上海帝博企业管理咨询有限公司

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职位介绍: 岗位职责： 1Take ownership of project management and product development, collaborating with cross-functional teams (R&D, PM) to define appropriate testing strategies and minimize product failures during new product introduction (NPI). 2Develop, approve and implement standardized methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure product quality and functionality. 3Design and execute experimental testing and data analysis to maintain quality performance, minimize defects and failure rates, and drive data-driven decision-making using statistical quality tools. 4Collaborate with suppliers and key stakeholders (US R&D, US PM, Sourcing, SQE, QE, QC, etc.) to resolve customer complaints, ensure effective implementation of CAPA/SCAR, and drive continuous supplier quality improvement. 5Ensuring quality decision making, compliance, and final release risk acceptance for both NCMR and Deviation processes. 6Identify and drive product and process improvement opportunities with suppliers to enhance quality performance and achieve cost efficiencies. 7Manage and oversee supplier-initiated change requests, ensuring changes are properly evaluated, validated, and implemented in compliance with quality and regulatory requirements 8Establish and maintain compliant product documentation (e.g., Device Master Records, technical files) and collaborate with Regulatory Affairs and suppliers to support regulatory submissions (e.g., 510(k), Letter to File). 9Provide expertise in product development, including Design Control, Risk Management, and compliance with applicable technical documentation requirements (e.g., CE Technical Files). 10Conduct thorough quality reviews of design and development documentation to ensure compliance with internal standards, regulatory requirements, and supplier quality documentation. 11Drive continuous communication and alignment with suppliers to ensure clear understanding and adherence to internal standards, regulatory requirements, and quality expectations. 12Coordinate product testing activities with internal and external laboratories to ensure timely and accurate execution of qualification and validation testing. 任职资格： Bachelor’s degree in mechanical engineering, Materials Engineering, Industrial Engineering, Medical Devices, or a related engineering discipline Minimum 5+ years of engineering experience, preferably with strong project management exposure. Hands-on experience in process control and quality control is required. Medical device quality background is preferred. -Understanding of quality system requirements (ISO 13485 or ISO 9001). -Proven ability to read and interpret product specifications, drawings, and technical documentation. - Demonstrates a professional attitude and a heightened sense of urgency to complete tasks accurately and efficiently. - Capable of identifying improvement opportunities in products, processes, and documentation, and driving implementation with suppliers and internal teams. - Strong leadership, collaboration, and influencing skills across cross-functional and cross-regional teams. - Proficient in engineering and office software tools, including MS Office (Word, Excel), and Adobe tools. -Experienced in key quality methodologies and tools, such as FMEA, Control plan, MSA, PPAP. - Willingness to travel frequently (≥30%) as required by project needs - Fluent in English (spoken, written, and reading). - Ability to manage special projects and assignments as directed by manager PREFERRED QUALIFICATIONS: Education Master’s degree in mechanical engineering, Materials Engineering, Industrial Engineering, Medical Devices, or a related engineering discipline, CQE or PMP certification is preferred Relevant Work Experience Minimum of 5 years of industry experience in medical devices, pharmaceuticals, or other relevant fields directly related to this role

其他信息: 语言要求：不限; 行业要求：医疗器械

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