HireDiversity

West Chester, PA, US

Worldwide Quality Systems Lead-6511130107

Description

Lifescan Inc, a member of the Johnson & Johnson family of companies, is recruiting for a Worldwide Quality Systems Lead, to be located in West Chester, PA.

LifeScan is the leading manufacturer of blood glucose monitoring systems in the U.S. More than 5 million people depend on the company's OneTouch® Brand Products for simple testing and accurate results to help them manage their diabetes. In addition, OneTouch® products are recommended by more Healthcare Professionals than any other brand. Consisting of a portable electronic meter and disposable reagent test strips, our systems provide results in just 5 seconds and include tools to help transform results into actionable health care decisions. To learn more visit www.OneTouch.com.

The WW Quality Systems Lead is responsible for the global management and oversight of the Document and Data Control process and procedures for the Worldwide Quality System & Compliance group. This individual provides global leadership, direction and development to all direct reports, ensuring performance is reviewed on a frequent basis. Leads Diabetes Franchise WW teams and ensures that the daily operations are in alignment with business needs. Ensures compliance with all applicable regulations. Manages a globally dispersed and culturally diverse workforce responsible for the daily execution within DCF Document and Data Control Process. Provides guidance to functional organizations and project teams across the Diabetes Care Franchise on Document and Data Control Process. Collaborates with local and global cross-functional groups to develop & deliver Process Improvements. Develops, records and presents Document and Data Control metrics to Management Review, and other management forums as required.

The WW Quality Systems Lead is the subject matter expert for Document and Data Control. This individual is the key support for internal and external audits. Executes Animas Quarterly Management Review Process. Deputizes as directed for WW Manager Quality Systems.

Qualifications


A Bachelor's degree and a minimum of 5 years of Quality Assurance or Quality Systems experience within the Medical Device & Diagnostic or other regulated industry is required. Process Excellence certification is preferred. ASQ Certification ( i.e. CQA, CQE) is preferred. People management experience is required.

Demonstrated knowledge of supply chain and research and development operations is an asset. The ability to influence and enroll business partners in the development and sustainability of the Quality System is required. A demonstrated track record of collaboration and teamwork in a cross-functional team environment is required. Experience with multiple, global quality systems implementations such as Document & Data Control, CAPA, Non-Conformances, and Design Controls to include the use of process excellence methodologies for new initiatives and process/system improvements is required.

Up to approximately 10% domestic and international travel may be required. This position will be located in West Chester, PA.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Lifescan Inc. (6097)