- Dedication toward ensuring patient safety, regulatory compliance and ongoing business success
- Drive the creation & effective execution of a robust supplier quality lifecycle management strategy for assigned commodities or product categories beginning with initial supplier/product qualification through retirement
- Drive execution and improvement of external supplier/product qualification process for assigned commodity or product categories
- Guide team members and supplier to greater levels of knowledge and application in Quality Management incl. Change Management, Corrective and Preventive Action (CAPA), Process Validation and Production/Process Controls, etc.
- Collaborate with peers, stakeholders, and team members to improve external supplier /product qualification procedures and documents to improve supplier oversight
- Identify and lead assigned continuous improvement projects for either suppliers or internal cross-functional teams
- Adhere to applicable regulations, standards and CAH quality management system requirement for medical devices and medicinal products
- Drive for corrective/preventive and continuous improvement activities to assure CAH supplier quality process effectiveness and avoid repeat issues
- Ability to lead and influence cross-functional teams, including Procurement, Regulatory Affairs, Technical Services and Research & Development to drive reduction in patient safety risk and greater levels of regulatory compliance
- Apply experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, and Risk Management (ISO to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance
- Excellent written and verbal communication skills to drive clear alignment of company and department goals
- Bachelor degree in Science or Engineering, advance degree preferred.
- At least 8-12 years experience in related fields, of which preferably 5 + years in manufacturing quality/Engineering quality/supplier quality in heathcare industry e.g. medical device
- Apply experience and knowledge of ISO Quality Management Systems), FDA medical device regulations, cGMP, and Risk Management (ISO to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance
- Solid experience/knowledge of quality process management and tools e.g. APQP, PPAP, SPC, Statistics Tools and Analysis in development and revision of Quality Sampling Plans based on product and patient risk.
- Ability to lead and influence cross-functional teams, including Procurement, Regulatory Affairs, Engineering and Research & Development to drive reduction in patient safety risk and greater levels of regulatory & quality compliance
- Proficiency in multi-tasking and working in a high-paced, matrixed environment with an awareness of continued impact on compliance and operational performance
- Excellent written and verbal communication skills to drive clear alignment of company and department goals
- Commitment to work within the ethos of the company mission, code of conduct and applicable legal standards/regulations
- Proficient English, working language for reading, writing and oral communication.
- Minimum % travel expected
- 致力于确保患者安全、法规遵从性和持续的业务成功
- 推动为指定商品或产品类别创建和有效执行强大的供应商质量生命周期管理战略,从最初的供应商/产品资格认证到退役
- 推动指定商品或产品类别的外部供应商/产品资格认证流程的执行和改进
- 指导团队成员和供应商在质量管理方面获得更高水平的知识和应用,包括变更管理、纠正和预防措施 (CAPA)、过程验证和生产/过程控制等。
- 与同行、利益相关者和团队成员合作,改进外部供应商/产品资格认证程序和文件,以改善供应商监督
- 为供应商或内部跨职能团队确定并领导分配的持续改进项目
- 遵守医疗器械和医药产品的适用法规、标准和CAH质量管理体系要求
- 推动纠正/预防和持续改进活动,以确保 CAH 供应商质量流程的有效性并避免重复问题
- 理工学学士学位,高级学位优先。
- 至少 8-12 年相关领域经验,其中5+年 医疗保健行业(例如医疗器械)的制造质量 /工程质量/供应商质量
- 运用 ISO 13485(质量管理体系)、FDA 医疗器械法规、cGMP 和风险管理 (ISO 的经验和知识,灌输致力于确保患者安全和持续合规的文化
- 在质量过程管理和工具方面有扎实的经验/知识,例如APQP,PPAP,SPC,统计工具和分析,以制定和修订基于产品和患者风险的质量抽样计划。
- 能够领导和影响跨职能团队,包括采购、法规事务、工程和研发,以推动降低患者安全风险并提高监管和质量合规性水平
- 熟练掌握多任务处理和在快节奏、矩阵式环境中工作,并意识到对合规性和运营绩效的持续影响
- 出色的书面和口头沟通技巧,推动公司和部门目标的明确一致性
- 承诺在公司使命、行为准则和适用的法律标准/法规的精神范围内工作
- 熟练的英语,阅读,写作和口头交流的工作语言。
- 预计至少 % 出差
-
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Senior Principal Engineer, Supplier Quality Management - Shanghai, 中国 - Cardinal Health
描述
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Supplier Quality is responsible for managing external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance, auditing supplier's quality management system to applicable regulations and quality standards, providing metrics, and addressing quality and regulatory issues.
Accountabilities:
____________________________________________________________________
质量管理制定并实施质量政策、程序和流程,以确保产品和服务符合监管标准和规范。
供应商质量负责在整个产品生命周期内管理外部供应商,包括评估和鉴定供应商、监控供应商绩效、根据适用法规和质量标准审核供应商的质量管理体系、提供指标以及解决质量和监管问题。
任职要求:
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
