HireDiversity

West Chester, PA, US

Staff Specialist, Quality Systems-8395130115

Description

Lifescan Inc, a member of the Johnson & Johnson family of companies, is recruiting for a Staff Specialist, Quality Systems, 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 Staff Specialist, Quality Systems is responsible for the Global Management and Implementation of Quality Systems process and procedures for the WW Quality System & Compliance group to include, but not limited to: CAPA / NC / D&DC / Training / Management Review / External Standards, ensuring focus on meeting regulatory, compliance and customer requirements. This individual is responsible for system management to include implementation, upgrades and enhancements. Ensures implementation of DCF and MD&D alignment. Responsible for prioritization of system changes and rollout DCF/MD&D Alignment Processes, and prioritization of changes.

The Staff Specialist, Quality Systems has oversight for consistency of Global Quality System Processes. Acts as an SME for Quality System processes to key stakeholders and for audits. Executes internal audit observations / NC / CAPA as required. Manages the Quality System and Records Management procedural documents including creation and revision and ensures J&J best practices are utilized on a local basis. Develops training materials (E Learning, other). Conducts concept training on Quality Systems. Advises on qualification creation, management and rollout. Responsible for meeting facilitation including creating agenda, compiling deck, taking meeting notes, action items and disseminating. Also responsible for facilitating the Global Review Board.

This individual develops Quality System metrics, analyzes data, provides conclusions, recommendations and resulting action plans. Presents metrics to review forums as required. Identifies and implements appropriate metrics to report and at which level. Ensures effective communication on process changes, procedural updates, establishment of best practices, system updates and changes. Leads, participates, and collaborates on Quality System projects/initiatives including representation of the Diabetes Franchise on MD&D projects/initiatives. Performs other work-related duties as assigned.

Qualifications


A Bachelor's degree and a minimum of 7 years of related experience is required. A scientific or engineering degree is preferred. Project Management experience including leading global, cross functional projects is required. Proficiency in using software systems, understanding of functionality, as well as the ability to liaise with IT on system enhancements and prioritization, suggest improvements, and translate needs into system requirements is required.

The ability to analyze and make decisions based on data gathered is required. The ability to create and execute a training program that is robust enough to help the user community through upcoming changes is preferred.

Knowledge and experience in quality systems is strongly preferred. Experience writing and revising procedural documents is preferred. The ability to multi task and define priorities is required. Strong reasoning abilty, problem solving, and troubleshooting skills are required. The ability to effectively communicate (orally or via written communication) changes, updates, and process improvements to the business partners or members of the organization are required. Experience implementing and deploying new processes and systems is required. The ability to create and present presentations is required. Experience creating agendas, writing minutes and follow-up actions is required. Process excellence training and/or certification is an asset. ASQ certification is preferred.

Up to approximately 20% international and domestic travel may be required. This position is located in West Chester, PA.

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