Product Quality Manager

该职位来源于猎聘 Main Responsibilities & Tasks: Product Development Quality Oversight

• Provide quality oversight throughout new product development, product modifications, and product lifecycle management activities for bioprocess products and solutions.
• Ensure quality requirements are integrated into product design, development, qualification, and commercialization processes.
• Participate in stage-gate reviews, design reviews, and development milestones to ensure compliance with applicable quality standards and requirements. Design Quality & Compliance
• Review and approve design inputs and outputs, product specifications, material specifications, acceptance criteria, and technical documentation.
• Ensure compliance with customer requirements, regulatory expectations, industry standards, and internal quality requirements throughout the design and development process.
• Serve as the Quality representative in cross-functional project teams, providing independent quality assessment and guidance. Risk Management & Quality Systems
• Apply risk-based quality principles and methodologies to identify, assess, and mitigate product, process, supplier, regulatory, and customer-related risks.
• Review and support risk assessments, design verification and validation activities, change controls, deviations, investigations, and CAPA processes.
• Ensure quality risks are appropriately documented, escalated, and resolved before product release. Product Quality Assurance & Commercial Readiness
• Define and support the implementation of product quality control strategies, including Critical-to-Quality (CTQ) attributes, inspection plans, testing requirements, and release criteria.
• Support supplier qualification activities to ensure materials and components meet product quality requirements.
• Contribute to PPAP, manufacturing process validation, process qualification, and product transfer activities to ensure readiness for commercial production.
• Ensure product quality documentation and records are complete, accurate, and audit-ready. Lifecycle Quality Management
• Support post-launch quality activities, including customer complaint investigations, root cause analysis, CAPA implementation, and continuous improvement initiatives.
• Monitor product quality performance throughout the product lifecycle and drive actions to maintain compliance, reliability, and customer satisfaction.
• Promote continuous improvement of product development quality processes, design control practices, and quality documentation standards. 职位要求： Qualifications & Skills: Qualifications and Experience
• Bachelor's degree in Engineering, Biotechnology, Life Sciences, Quality Management, or a related technical discipline; Master's degree preferred.
• Minimum of 7 years of experience in Product Quality, Design Quality, Quality Assurance, Quality Engineering, or Product Development within the life sciences industry.
• Experience in bioprocessing, biotechnology, pharmaceuticals, medical devices, or related regulated manufacturing environments is highly preferred.
• Proven experience supporting product development projects from concept through commercialization. Knowledge and Skills
• Strong knowledge of Quality Management Systems (QMS) and product development processes.
• Solid understanding of applicable quality and regulatory requirements, including ISO 9001, GMP, GDP, and other relevant industry standards.
• Hands-on experience with design controls, risk management methodologies, design reviews, specification management, verification and validation, change control, deviations, nonconformances, investigations, and CAPA processes.
• Strong understanding of product lifecycle management (PLM) and technology transfer from development to manufacturing.
• Excellent analytical, problem-solving, communication, and stakeholder management skills.
• Ability to work effectively in a cross-functional and global matrix environment.
• Fluent in both written and spoken English. 隐私政策 [赛多利斯斯泰帝（上海）贸易有限公司]和/或其关联公司（“公司”）注重个人信息的保护，遵守适用的个人信息保护法律法规处理个人信息。 在您申请职位之前，请仔细阅读下述声明。[通过点击“同意”按钮或]直接向公司提供您的个人信息即被视为您接受并完全同意以下条款。 1. 您确认，您就本次申请所提交的信息正确无误。若信息有任何严重不实之处，公司有权拒绝您的申请或解聘您与公司的劳动关系。如果您在公司登记的信息发生变更，您应及时通知人力资源部。 2. 您确认并同意，公司可以为了合法的雇佣相关目的在中国境内外收集、存储、使用、共享、转让、披露您的个人信息，具体而言： A. 个人信息的收集 * 职位申请。在提交应聘申请时，公司将收集您在申请中提供的信息，包括姓名、电话号码、电子邮件地址、教育背景、工作经历、专业技能、简历、其他您主动提供的信息等。 * 背景调查。公司及/或其授权代理人可能对您的背景和关于您的其他信息进行调查核实，从您的前雇主以及任何掌握您背景信息的第三方收集您个人信息。您授权公司及/或其授权代理人对您的背景和关于您的其他信息进行调查核实。并且，您授权您的前雇主以及任何其他人或组织提供其掌握的关于您背景的任何准确信息。您同意，若公司要求，您将在信息核查方面给予配合。 B. 个人信息的使用 公司将出于处理您的申请、评估您的工作能力和资格、个人材料的核实、人力资源管理、背景审查、调查和其他合法的雇用/业务相关目的使用已收集的个人信息。 C. 个人信息的存储、共享、转让、披露 公司将已收集的个人信息传输并存储在收集个人信息时您所在的国家或地区之内或之外。同时，公司还可能将已收集的个人信息为本隐私政策所述之目的与全球的公司的关联公司共享和转让。就上述个人信息的传输、存储、共享和转让，公司将确保根据适用法律所要求的提供充分的个人信息保护措施。 公司可能为遵守适用法律、法庭命令或其他法律程序、或根据有管辖权的监管机关的要求披露已收集的个人信息。 D. 信息的保留 除非适用法律另有规定，公司仅在为实现根据本政策所述之目的所需要的时限内保留已收集的个人信息。 E. 您的权利 作为个人信息主体，您知晓自己有权 (i) 访问公司存储并处理的您的个人信息，(ii) 要求更正、更新并删除您的个人信息，以及 (iii) 撤回处理您个人信息的同意。