Principal Supplier Quality Auditor
3 weeks ago
Quality & Regulatory Audit is responsible for assessing processes and practices for regulatory risk and conformance to quality standards, and working with business and quality leaders to implement improvements.
Conducts thorough Quality Management System, Process, and/or Product audits of all assigned Raw Material, Component, Services or Finished Goods Suppliers Demonstrates comprehensive knowledge of regulatory requirements in their respective areas, as well as auditing techniques Assists in analyzing regulatory requirements and overall program compliance to determine enterprise risk Manages applicable internal corrective actions in response to audit findings to ensure effectiveness and avoid repeat issues Identifies and proposes audit program enhancements Ensures compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation. Communicates best practices observed to other business units. Prepares for audits by researching materials, standards, policies and procedures to formulate a plan of action. Leads the escalation process for unacceptable audits to appropriate management representatives Apply experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, MDSAP (Medical Device Single Audit Program) and Risk Management (ISO 14971) to instill a culture dedicated to regulatory compliance Knowledge of business platforms and processes such as Veeva Vault, SAP, BPCS and Agile PLM Ability to multi-task and work in a high paced environment with an awareness of continued impact on compliance and operational performance Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans Excellent written and verbal communication skills to drive clear alignment of company and department goals The ability to take responsibility for the professional development of you and your colleagues Commitment to work within the ethos of the company mission, code of conduct and applicable legal standards/regulations Bachelors in related field preferred, or equivalent work experience, preferred 4+ years of experience in related field, preferred Experience performing Quality System audits in the Medical Device or other regulated industry. Current knowledge of GMP auditing & regulation (FDA 21 CFR 820 & 21 CFR 210/211, & ISO13485) & international quality system requirements Language Skills: Ability to read, analyze and interpret quality system documents, records, and technical procedures. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information to groups of managers, clients, and the general public. Certificates, Licenses, Registrations: Certified Quality Auditor (CQA) to ASQ CBA, ASQ CQA, or ISO Lead Auditor training by an accredited organization and/or Certified Quality Engineer (CQE) strongly preferred. Up to 50%-70% of travel required. Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects May contribute to the development of policies and procedures Works on complex projects of large scope Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives Completes work independently receives general guidance on new projects Work reviewed for purpose of meeting objectives May act as a mentor to less experienced colleaguesCandidates 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.
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Principal Supplier Quality Auditor
2 weeks ago
Shanghai, Shanghai, China Cardinal Health Full timeWhat Quality & Regulatory Audit contributes to Cardinal Health Quality & Regulatory Audit is responsible for assessing processes and practices for regulatory risk and conformance to quality standards, and working with business and quality leaders to implement improvements. Responsibilities Conducts thorough Quality Management System, Process, and/or...
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Principal Senior Auditor
3 weeks ago
Shanghai, China Swiss Re Full timeAbout the Role As a Principal Senior Auditor for Group Internal Audit, you will work within an agile framework in which you will self-organize with your peers to support the Audit Directors to oversee the performance and execution all relevant audit activities related to Swiss Re's activities and business to Swiss Re's activities in the Asia Pacific...
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Principal Senior Auditor
2 weeks ago
Shanghai, Shanghai, China Swiss Re Full timeAbout the Role As a Principal Senior Auditor for Group Internal Audit, you will work within an agile framework in which you will self-organize with your peers to support the Audit Directors to oversee the performance and execution all relevant audit activities related to Swiss Re's activities and business to Swiss Re's activities in the Asia Pacific region...
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Senior Supplier Quality Engineer
4 weeks ago
Shanghai, China Quality & Process Engineering Full timeThe position Overall Purpose of the Role: Supplier Quality management is key component of Automotive product Quality assurance. SQE is responsible for delivering all aspects of the Supplier Quality Assurance function. SQE is expected to:· Work in a team environment with suppliers to develop and implement best practices that emphasize defect...
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Principal Senior Auditor
1 week ago
Shanghai, China Swiss Re Full timeAbout Swiss ReSwiss Re is one of the world's leading providers of reinsurance, insurance and other forms of insurance-based risk transfer, working to make the world more resilient. We anticipate and manage a wide variety of risks, from natural catastrophes and climate change to cybercrime. We cover both Property & Casualty and Life & Health. Combining...
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Principal Senior Auditor
2 weeks ago
Shanghai, Shanghai, China Swiss Re Full timeAbout Swiss Re Swiss Re is one of the world's leading providers of reinsurance, insurance and other forms of insurance-based risk transfer, working to make the world more resilient. We anticipate and manage a wide variety of risks, from natural catastrophes and climate change to cybercrime. We cover both Property & Casualty and Life & Health. Combining...
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Principal Senior Auditor
1 week ago
Shanghai, Shanghai, China Swiss Re Full timeAbout Swiss ReSwiss Re is one of the world's leading providers of reinsurance, insurance and other forms of insurance-based risk transfer, working to make the world more resilient. We anticipate and manage a wide variety of risks, from natural catastrophes and climate change to cybercrime. We cover both Property & Casualty and Life & Health. Combining...
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Principal Associate-Quality Auditor–GQAAC
2 weeks ago
Shanghai, Shanghai, China Lilly Full timeWe're looking for people who are determined to make life better for people around the world. This job position is for a GCP medical auditor. The position is office-based located at the Lilly Beijing or Shanghai affiliate office. Position Brand Description: The Quality Auditor is part of the Global Quality Auditing and Compliance (GQAAC) division and...
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Principal Associate-Quality Auditor–GQAAC
4 weeks ago
Shanghai, China Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. This job position is for a GCP medical auditor. The position is office-based located at the Lilly Beijing or Shanghai affiliate office. Position Brand Description: The Quality Auditor is part of the Global Quality Auditing and Compliance (GQAAC) division...
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Principal Supplier Quality Auditor
3 weeks ago
Shanghai, China Cardinal Health Full timeWhat Quality & Regulatory Audit contributes to Cardinal Health Quality & Regulatory Audit is responsible for assessing processes and practices for regulatory risk and conformance to quality standards, and working with business and quality leaders to implement improvements. Responsibilities Conducts thorough Quality Management System, Process, and/or...
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Supplier Quality Engineer
2 weeks ago
Shanghai, Shanghai, China Humanscale Full timeOverview The Supplier Quality Engineer will be responsible for assuring Humanscale's product quality, improving manufacturing process and working closely with the supplier in solving the technical and quality problems within Asia regions. The ideal candidate for this position must be a passionate and proactive engineer with strong knowledge in quality...
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Supplier Quality Engineer
4 weeks ago
Shanghai, China Humanscale Full timeOverview The Supplier Quality Engineer will be responsible for assuring Humanscale's product quality, improving manufacturing process and working closely with the supplier in solving the technical and quality problems within Asia regions. The ideal candidate for this position must be a passionate and proactive engineer with strong knowledge in...
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Supplier Quality Engineer
2 weeks ago
Shanghai, Shanghai, China Cardinal Health Full timeLocation: China-Shanghai Sourcing Office, Kerry Everbright City Reports to: SeniorQuality Manager (based in Shanghai) The Company and Business Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems,...
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Shanghai, China Western Digital Full timeJob DescriptionJob DescriptionOwn all aspects of supplier quality and reliability for integrated circuit (IC), voltage regulators, electrolytic & polymer capacitor. Work with suppliers, along with hardware, firmware, product quality and reliability engineering teams to ensure electrical component performance in WD products. Understand supplier processes...
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Shanghai, China Western Digital Full timeJob DescriptionJob DescriptionOwn all aspects of supplier quality and reliability for connector components. Work with suppliers, along with hardware, firmware, product quality, customer support and reliability engineering teams to ensure electrical component performance in WD products. Understand WW connector standard, WD unique requirement and supplier...
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Shanghai, China Western Digital Full timeCompany Description At Western Digital, our vision is to power global innovation and push the boundaries of technology to make what you thought was once impossible, possible. At our core, Western Digital is a company of problem solvers. People achieve extraordinary things given the right technology. For decades, we’ve been doing just that. Our...
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Senior Engineer, SFMD Supplier Quality
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Shanghai, China Boston Scientific Full timeAbout the role: The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional...
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SSME MP Supplier Quality Engineer
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Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full timeJoinus in pioneering breakthroughs in healthcare. For everyone. Everywhere.Sustainably. Ourinspiring and caring environment forms a global community that celebratesdiversity and individuality. We encourage you to step beyond your comfort zone,offering resources and flexibility to foster your professional and personalgrowth, all while valuing your unique...
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Senior Engineer, SFMD Supplier Quality
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Shanghai, Shanghai, China Boston Scientific Full timeAdditional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools,...
