上海招聘

职位描述：
Responsibilities
? The Quality Manager oversees the entire Quality Assurance Department in Shanghai which includes both Skin & Wound Management (SWMPL) and Surgical Medical Products (SMP) groups and also responsible for overseeing all regional quality functions in China, which include developing quality standards / requirements, quality planning, reporting, procedure development, processor and supplier quality, implementation of company quality strategy, quality education, ensuring quality systems and processes are in full alignment with company expectations and requirements, ensuring new product development is effectively managed by usage of qualification protocols, and assisting with supply chain management.
? Lead and manage all aspects of Supplier Quality Management including: establishment of a “best in class” Supplier Quality organization, development and implementation of robust quality operating processes and procedures to enhance the quality of goods received, segmentation of the supply base to focus on the largest supplier quality improvements, travel to suppliers within China to ensure quality expectations are well understood and delivered, management reporting in regards to supplier quality and cooperation with other sites and departments to ensure organizational alignment.
? Partners with Operations, Quality, R&D, Technical Services, Sourcing and Suppliers (Contract Manufacturers) for compliance to specifications, quality/regulatory standards and continuous improvements.
? Collaborates with new & existing Product Development / Improvement Teams and Project Teams to ensure quality standards are met.
? Oversees supplier quality activities such as supplier qualification, supplier corrective actions, supplier audits, inspection plans, first articles, root cause analysis, metrics and supplier performance.
? Work with Singapore Management and Supply Chain to further develop, optimize and improve processes which would affect ISO 9001, ISO13485 and other Quality Standards Requirements. Define and specify the improvement and implementation of Quality Systems Standards, methods and processes supporting the developments, qualification, testing and validation of the safety, efficacy and reliability of company products made by processors and suppliers.
? Provide Quality Assurance leadership direction, training and expertise in all aspects of Quality in the manufacture, supply chain, and testing of all products. Ensure sustainable high performance of our diverse and ever expanding processor and supplier portfolio. Lead the resolution of issues within the processors / suppliers and supply chains, with usage of data, quality tools, statistical applications, PDCA and etc. to make decisions. Ensure that corrective and preventive action processes within the facilities are effectively identifying the root cause of issues, implementing corrective and preventive processes and validating plans ensuring quality systems are effective and problem resolution are implemented.
? Establish and assure adherence to budgets, schedules, work plans and performance requirements. Select, develop and coach employees to ensure the effective operation of the function. Establish clear goals and performance expectations for all processors/ suppliers and direct reports; continuously assess performance and capabilities relative to goals and future business requirements.
? Develop and implement plan to ensure timely execution of all key tasks and initiatives such as supplier qualification, audits, supplier quality monitoring and performance improvement etc. In specific, provide daily oversight with established mechanism to ensure the following:
o Carry out management of Supplier Quality in China including qualification of new suppliers, routine audits, product inspections, ongoing surveillance and review of performance to ensure Cardinal Health’s requirements are consistently met;
o Ensure that products produced under agreements with Cardinal Health meet all quality and regulatory requirements;
o Support the Central Document Control (CDC) located in Singapore in maintaining documented Quality system in accordance with ISO 13485 and United States FDA Quality System Regulations;
o Ensure supplier takes appropriate corrective actions to address customer complaints and provide response to customers through CDC in Singapore;
o Liaise with other Cardinal Health businesses in Singapore and US to identify quality requirements.
? Participate with Management in the establishment of strategic and comprehensive quality plans and objectives that are comprehensively aligned with the companies objectives. Execute and coordinate objectives in collaboration with the processors and suppliers with ISO 9001, ISO 13485 and United States FDA Quality System Regulations.
? Provide quality leadership supports to other Cardinal businesses in China, and collaborate with other quality function leader to build Cardinal-wide quality organization in the region.

Requirements:
? Minimum 8 years experiences with at least 3 years in a quality leadership capacity, with track records in leading quality team
? Expertise in quality control & assurance, supplier quality audit & supplier development, preferably in Medical Device industry
? Great team leadership with strong inter-personal and influencing skills, ability to effective manage and coordinate within a matrix organization
? Passion for quality with a zero-error mentality; willing to “go the extra mile
? Self-initiator and solution provider with self-dependent trouble shooting mentality, is hands-on and “getting things done” oriented
? Strong communication skill in both English & Chinese, good analytical skill and process mind-set, ability to drill into complex quality/processes issues
? Willing to travel both internationally and domestically within China
? Graduate in Science or Engineering, a Medical major or MBA is a plus
? Team player. 举报 分享

About Cardinal Health

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $99 billion health care services company that improves the cost-effectiveness of health care.

As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers and physician offices focus on patient care while reducing costs, improving efficiency and quality, and increasing profitability.

Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products to more than 60,000 locations each day.

The company is also a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease.

Ranked #17 on the Fortune 500, Cardinal Health employs more than30,000 people worldwide.

About Cardinal Health Medical Segment Shanghai Office

Cardinal Health Medical Segment Shanghai Office was established in 2003 and managed by Singapore office. In Feb. 2012, it changed to WOFE as Cardinal Medical Equipment Consulting (Shanghai) Co., Ltd.

We have two main businesses in China: global sourcing and convertors manufacturing. Global sourcing team cooperates with U.S. sourcing team to search for more resources in Asia in medical-surgical products to ambulatory care centers, physician offices, clinical laboratories and hospitals. Covertors manufacturing team focus on high-volume replenishable products such as gloves, gowns, surgical drapes, scrubs and fluid management products from suppliers in China.