上海招聘

职位描述：

RESPONSIBILITIES

• Outsourcing party/supplier assessment, qualification and quality plan & control on production
• Outsourcing party/supplier performance monitoring and improvement
• Ensure quality system of Outsourcing party/supplier compliant with ISO13485/QSR 820
• Initiatively lead and involved in process optimization program
• Product change evaluation and follow-up
• Manage QA inspection activities
• Work closely with outsourcing party/supplier to perform process validation and conduct shipping approval inspection
• Coordinate complaint /non-conformance investigation at outsourcing party/supplier
• Participate in new product launch/transfer by identifying quality requirements
• Establish FMEA, Control Plan, SPC and CPK control and develop the application of QC tools.

REQUIREMENTS

• Possess Diploma/ University degree in Science or Engineer discipline
• Be familiar with injection modeling
• Minimum 2 years medical device experience in quality operations or quality engineering. Familiarity in

managing contract manufacturers /suppliers

• Lead assessor qualification for quality system/ process audit is an advantage
• Resourceful, organized and able to work independently in an fast paced environment
• Able and willing to travel extensively within China
• Good communication, interpersonal skill .English skill required
• Knowledgeable in ISO13485 or FDA GMP/QSR 820 or equivalent quality system
• Team player
• Knowledge on Lean Six Sigma is preferred.

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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.