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Senior Manager Quality Operations

Company: J&J Family of Companies
Location: San Angelo
Posted on: June 10, 2021

Job Description:

Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Operations Manager based in San Angelo, TX. Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit . Under the direction of the Plant Quality Assurance Director and with the objective of maintaining high quality standards for the product manufacturing process and compliance with regulatory requirements, coordinates Quality Assurance support for the site including project support. Directly leads Quality Engineers and non-exempts in day to day activities supporting manufacturing, non-conforming material management and finished good release, all in accordance with applicable regulations and Ethicon written specifications and quality standards. + Coordinates the deployment and utilization of resources for tactical day-to-day work. This includes working with Operations, Engineering, Material Management, and QA. + Responsible for employee Coaching, Development, Succession Planning, Goals and Objectives, and Salary planning for direct reports and subordinates. + Formulates and maintains quality control objectives and coordinates objectives with preproduction and production procedures in collaboration with other manufacturing managers to improve product reliability and minimize costs. + The individual has the independence, authority, and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality issues, initiate, recommend, provide and verify solutions. + Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems. + Acts as back up to QA Director for signature authority and meeting representation. + Submits and coordinates budget schedules and performance standards. + Coordinates the control of raw material, work in process material, and finished goods to ensure proper identification, segregation, and control. + Ensures that performance and quality of products conform to established company and regulatory standards. + Analyzes data sources, significant quality trends, and recommends actions as needed. + Reviews and approves non-conformances, CAPA, Audit Observations, Change Controls, Validations and Completion Reports, and other quality system documents or records as the need arises. + Ensures effective risk management process is implemented to prevent unanticipated failure. + Supports and leads cost improvement projects. + Actively supports other plant functions in the implementation of company programs and projects. Enforces, promotes, and observes all safety, environmental, industrial hygiene rules and regulations established by the Company. Qualifications + Bachelor degree required; degree concentration in a Technical or Science field highly preferred. + A minimum of 8 years related professional (Quality Operations, Quality Systems, Quality Engineering, Compliance, Regulatory, etc.) experience in a highly regulated industry required. + Medical device or pharmaceutical or similar industry experience highly preferred. + Experienced people manager; leadership experience including direct supervision required. + Experience working in Quality operations supporting a production/manufacturing environment is required. + Front room experience with FDA (or similar) and/or notified bodies (ISO 13485, etc.) preferred + Knowledge of lean manufacturing and manufacturing processes preferred. + Certification in PE tools preferred. + Strategic thinker with strong leadership ability, interpersonal, communication, and influencing skills is required. + The ability to foster a productive team-oriented environment, handle multiple assignments, and display flexibility in response to an environment with rapidly shifting priorities required. + Position requires ~10% travel domestic & international Johnson & 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 Location United States-Texas-San Angelo-3348 Pulliam Street Organization Ethicon Inc. (6045) Job Function Quality Requisition ID 2105913508W

Keywords: J&J Family of Companies, San Angelo , Senior Manager Quality Operations, Other , San Angelo, Texas

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