Principal Supplier Quality Auditor
5 months ago
What 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 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 representativesAccountabilities
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/regulationsQualifications
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.What is expected of you and others at this level
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.
To read and review this privacy notice click here
-
Shanghai, Shanghai, China Western Digital Full timeJob OverviewWestern Digital is seeking a highly skilled Principal Engineer to lead our supplier quality and reliability efforts for integrated circuit (IC) and capacitor components. As a key member of our quality engineering team, you will be responsible for ensuring the electrical component performance in our products.Duties and ResponsibilitiesManage all...
-
Principal Engineer Supplier Quality Engineering
1 month ago
Shanghai, Shanghai, China Western Digital Full timeAbout Western DigitalAt Western Digital, we're a company of problem solvers. We believe that technology has the power to make the impossible possible. Our team is dedicated to pushing the boundaries of innovation and creating a brighter, smarter future.Job SummaryWe're seeking a highly skilled Principal Engineer, Supplier Quality Engineering to join our...
-
Supplier Quality Management Engineer
2 weeks ago
Shanghai, Shanghai, China Siemens Energy Full timeSupplier Quality Management EngineerAbout the RoleOverviewAs a Supplier Quality Management Engineer at Siemens High Voltage Switchgear Co., Ltd., Shanghai, you will play a vital role in ensuring the quality of high-voltage components meets the required standards. Your expertise will be instrumental in driving supplier process and product qualification...
-
Supplier Quality Engineer
6 months 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...
-
Supplier Quality Assurance Specialist
2 weeks ago
Shanghai, Shanghai, China Humanscale Full timeJob OverviewThe Supplier Quality Engineer will play a key role in ensuring Humanscale's product quality, improving manufacturing processes, and collaborating with suppliers to resolve technical and quality issues in Asia. We seek a dedicated and proactive engineer with expertise in quality systems and experience in metal stamping, aluminum die...
-
Shanghai, Shanghai, China Cardinal Health Full timeJob Summary:Cardinal Health is seeking a Senior Quality Engineer to lead the quality activity in supplier qualification, supplier quality management, CAPA, and process check. The ideal candidate will have a minimum of 5 years of quality control/quality assurance experience in the medical device industry.Duties & Responsibilities:Lead the selection,...
-
Principal Engineer, Supplier Quality Engineering
4 months ago
Shanghai, China Western Digital Full timeJob DescriptionOwn all aspects of supplier quality and reliability for Passive component electronics. Work with suppliers, along with hardware, firmware, product quality and reliability engineering teams to ensure WD product devlopment. Understand supplier processes to identify and control KPIV parameters to ensure achievement of KPOVs critical for WD...
-
Principal Engineer, Supplier Quality Engineering
5 months ago
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...
-
ICT Auditor
4 weeks ago
Shanghai, Shanghai, China DNV Full timeJob Summary:We are seeking a highly skilled ICT Auditor to join our team at DNV. As an ICT Auditor, you will be responsible for ensuring the quality and integrity of our certification processes.Key Responsibilities:Carry out audits and deliver services to our customers in a professional and efficient manner.Meet your own KPI targets and contribute positively...
-
Shanghai, Shanghai, China Parexel Full timeTransforming Quality ExcellenceOverviewParexel is seeking a highly skilled Senior Quality Assurance Auditor/Compliance Manager to lead and coordinate internal audits and audit programs, ensuring the highest standards of quality and compliance across the organization.Key ResponsibilitiesPlan and conduct complex audits, including project-related audits, system...
-
Medical Device Auditor
3 days ago
Shanghai, Shanghai, China DNV Full timeJob OverviewDNV seeks a highly skilled Medical Device Auditor to enhance quality assurance in the medical device industry.
-
Principal Engineer, SQE(Electrical Components)
4 weeks ago
Shanghai, Shanghai, China Western Digital Full timeJob SummaryWe are seeking a highly skilled Principal Engineer, SQE(Electrical Components) to join our team at Western Digital. The successful candidate will be responsible for owning all aspects of supplier quality and reliability for Passive component electronics.The ideal candidate will have a strong background in electrical engineering and experience...
-
Supplier Quality Engineer
4 weeks ago
Shanghai, Shanghai, China Siemens Energy Full timeSupplier Quality EngineerAbout the RoleAs a Supplier Quality Engineer at Siemens Energy, you will be responsible for ensuring the quality of products from our suppliers meets our high standards. You will work closely with internal teams and suppliers to develop and optimize manufacturing processes, conduct quality audits, and drive corrective actions.Key...
-
Supplier Quality Engineer
4 weeks ago
Shanghai, Shanghai, China Kohler Co. Full timeSupplier Quality EngineerAt Kohler Co., we are seeking a highly skilled Supplier Quality Engineer to join our team. This role will be responsible for managing supplier quality and ensuring that our products meet the highest standards of quality.Key Responsibilities:Develop and implement supplier quality management strategiesConduct supplier audits and...
-
Supplier Quality Engineer
4 months ago
Shanghai, China Metso Full timeJoin an industry leader and make a positive change in the sustainable use of the world’s natural resources. Together, we will transform the business and drive the industry toward a greener future. At Metso, you will be supported by our inclusive culture and a network of colleagues from around the world. With us, you will embark on a personal growth...
-
Principal Designer
3 days ago
Shanghai, Shanghai, China Benoy Full timeJob Title: Principal DesignerWe are seeking an experienced and talented designer to join our team as a Principal Designer at Benoy. This is a fantastic opportunity to work with a global design firm, collaborating with a diverse group of professionals to deliver high-quality projects.Estimated Salary: $80,000 - $110,000 per yearJob Description:Company...
-
Supplier Quality Assurance Specialist
2 days ago
Shanghai, China Johnson Controls Full timeJob Overview: The Supplier Quality Assurance Specialist will be responsible for rebuilding the Supplier Quality Assurance team in Asia, following the transition of the former team to JCI APAC or HGLS. This role focuses on improving supplier quality and performance, resolving supplier quality issues, and conducting assessments for both potential and...
-
Global Supplier Services Operation
5 months ago
Shanghai, China JPMorgan Chase & Co. Full timeOverview of the Role JPMorgan Chase seeks to do business with suppliers who provide the best price, quality and capability to meet our business needs. Global Supplier Services (GSS) brings together Sourcing, Third Party Oversight, Procurement Operations, and Accounts Payable into one team. This group of nearly 800 employees (in 11 countries) manages...
-
Supplier Quality Assurance Specialist
1 month ago
Shanghai, Shanghai, China Metso Full timeAbout the RoleMetso is seeking a highly skilled Supplier Quality Assurance Specialist to join our MIN Procurement China team. As a key member of our team, you will be responsible for ensuring the quality of our suppliers' products and services, ensuring compliance with Metso's quality standards and customer requirements.Key ResponsibilitiesAnalyze suppliers'...
-
ICT Auditor
6 months ago
Shanghai, China DNV Full timeCarry out and deliver the services to our customer in an efficient and professional manner as required by his Team Leader and/or formal agreements with clients Responsible to meet his/her own KPI-targets to carry out the work for DNV in an efficient and professional manner to be responsible for quality of his/her own work to contribute...
