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Quality Engineering Leader, Medical Device

Company: Johnson & Johnson
Location: Cincinnati
Posted on: July 19, 2019

Job Description:

Ethicon a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Quality Engineering Leader (Quality Systems Integration for Megadyne) to be located in Cincinnati, OH or Draper, UT.This position will manage the quality system integration of Megadyne Medical Products into the Ethicon and Johnson and Johnson quality system.Key ResponsibilitiesThis person will provide leadership and project management skills to plan, organize, gain buy-in for, and execute activities required to ensure Megadyne meets the Quality Systems Requirements of Ethicon and Johnson and Johnson.In this role, you will help to harmonize the quality system procedures, processes, and systems at Megadyne with those of Ethicon and Johnson and Johnson. The QE Leaders will supervise individuals assigned to projects related to the quality system integration.This person will collaborate with cross-functional teams at Megadyne and Ethicon to support the overall integration effort of Megadyne into Ethicon and Johnson and Johnson.This person will communicate progress of quality integration efforts and quality system compliance risks. In this role, you may be asked to support internal and external audits, non-conformances, and CAPAs.Other responsibilities may be assigned.QualificationsBachelors Degree is required in engineering or related technical field 6+ years related experience required 1-2 years supervisory experience, preferred Managing people and projects which lead to positive, tangible business results, requiredDirect experience with FDA inspections in a leadership role, is required Experience with progressive quality systems, quality control, quality assurance, including hands on advanced quality systems compliance is required Detailed knowledge of medical devices regulatory requirements is necessary. Experience in the medical devices or pharmaceutical industry is preferred. Possess a demonstrated track record of achieving successful complianceProven success in: Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change. Demonstrates the ability to engage in constructive conflict. Must have strong collaboration and influence management skills to partner effectively with Operating Company functions and across Operating Units. Proven track record of demonstrating collaboration across the organization and at all levels Building consensus and impacting outcomes without always having reporting line authority; able to negotiate trade-off decisions across the organization. Compliance experience and large-scale QMS experience, preferredStrong analytical skills and experience implementing risk-based oversight programs across multiple sites or corporate experienceChange management and project management experience Strong executive presentation skills Effect and influence - systems-level change, gain cooperation and action from others Communication - demonstrate the ability to discuss complex quality issues and concepts in a clear and concise manner, orally and in writing - with all levels of management This position will be located in either Draper, UT or Cincinnati, OH and may require up to 50% travelJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary LocationUnited States-Ohio-Cincinnati-OrganizationMegaDyne Medical Products, Inc. (6250)Job FunctionQuality (Eng)Requisition ID

Keywords: Johnson & Johnson, Lexington , Quality Engineering Leader, Medical Device, Healthcare , Cincinnati, Kentucky

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