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Senior Quality Engineer

Company: Johnson & Johnson
Location: Irvine
Posted on: April 9, 2021

Job Description:

Job Description

Ethicon, part of the Johnson & Johnson Medical Devices Companies is recruiting for a Senior Quality Engineer to be based at any of the Medica Device locations in US.

This role can be based at any of the Medical Device locations but not limited to West Chester, PA, Cincinnati OH, Sommerville, NJ, Warsaw, IN, San Angelo, TX, Redwood City CA, Irvine, CA, Palm Beach gardens, FL, Raynham, MA, Atlanta GA.

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 .

The Quality Engineer (QE) supports the CAPA and Nonconformance (NC) process for Ethicon as a site lead through supporting data analysis, assurance of robust failure investigation and content, monitoring of CAPA & NC process metrics and serving as a mentor for failure investigations, while constantly seeking continuous improvement opportunities. The QE must also collaborate across the Ethicon Franchise to support the harmonization and integration of an optimized Medical Device CAPA & NC process.

Duties & Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

  • Mentoring CAPA & NC owners and approvers with a focus on content from failure investigation, root cause identification through action plan deployment and effectivity monitoring.
  • Provide education as needed regarding CAPA & NC process
  • Provide CAPA & NC data analysis, queries, and reports
  • Provide mentorship for efficient execution
  • Maintain regular collaborate with Management to achieve company's Quality goals
  • Develop proactive and collaborative working relationship across key functions, including R&D, Quality Ops, Supply Chain and others, delivering results within the matrixed organization
  • Support FDA, BSI and any other Health Authority audit/ inspection as CAPA & NC SME for HQ site audits
  • Deliver results in the matrixed organization and foster continuous improvement in the CAPA process
  • Responsible for communicating business related issues or opportunities to next management level
  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed


    • A BS degree in Engineering, Sciences, or Business Analysis is required
    • Experience working in an FDA regulated environment is required
    • Minimum of 4 years of experience working in an Operations, Manufacturing, Quality and/or Engineering role is required
    • Strong communication, human relation, problem solving and analytical skills are all required
    • Demonstrated skills in root cause analysis and failure investigation are required
    • Ability to communicate effectively with all levels of management and functions is required
    • Demonstrated proficiency in problem solving skill sets and good analytical skills
    • Demonstrated leadership skills without direct authority responsibility
    • Demonstrated effectiveness as a team member and a team leader
    • This position can be based at any of the medical devices location and may require up to 25% of domestic or international travel

      • Demonstrated Project Management skills with a strong results orientation
      • Strong in ability to build collaboration, partnership and teamwork across local and global organizations
      • Experience in dealing with audits/ inspections with the FDA, other notified bodies or any other Health Authority

        Company Disclaimer

        Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

        We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

        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.

Keywords: Johnson & Johnson, Irvine , Senior Quality Engineer, Engineering , Irvine, California

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