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Quality Systems Lead

Company: Johnson & Johnson
Location: Irving
Posted on: November 22, 2022

Job Description:

Job Description - Quality Systems Lead (2206071357W) Quality Systems Lead - 2206071357W Description MENTOR, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Systems Lead Manager -to be located in Irving, Texas in the Dallas metropolitan area. Mentor was founded in 1969 and has a long, proud history as a global leader in breast aesthetics. For over 50 years, our company has rooted itself in a commitment to high-quality breast implants, science-based innovations and the best results for patients. We've maintained high standards of design, testing and safety, and we've earned the respect of the breast aesthetics community worldwide for our leadership. Being a part of the Johnson & Johnson Family of Companies, we aspire to be the trusted partner in breast aesthetics among both consumers and professionals. By providing a broad range of innovation and clinical-based solutions we aim to help women maintain, enhance, and restore self-esteem and quality of life. The Quality Systems Lead Manager will guide -the day-to-day operations of the Quality Systems staff. Oversees the development and implementation of processes, procedures, and corrective actions. Ensures effective communication for Quality Systems requirements throughout the business. The Quality Systems Lead Manager is responsible for the overall management and effectiveness of the site Document Control, Records Management, Nonconformance (NC) and Corrective and Preventive Action (CAPA) programs including: Administration of the Document Control, Records Management, NC, and CAPA systems, facilitation of the local Data Review Board and Management Reviews, coordination and support of NC and CAPA project teams, data trending and Change Management/NC/CAPA reporting and communication with management, team leaders, and auditing bodies. 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:

  • Manage the NC and CAPA processes and systems for the site.
  • Manage the Document Control and Records Management processes for the site.
  • Manages the implementation and administration of quality management systems in accordance with applicable standards.
  • Requests data and metrics reports obtained from quality databases and files for inclusion in management reports.
  • Examines results from management reviews, third party inspections and internal audits and approves proposed corrective actions.
  • Represent the site on the world-wide Document Control, Records Management, NC and CAPA teams.
  • Work effectively with other Document Control, Records Management, NC, and CAPA site leaders to ensure consistent systems and processes.
  • Provide education and mentoring as needed regarding Document Control, Records Management, NC, and CAPA.
  • Develop and implement measures to monitor the effectiveness of the Document Control, Records Management, NC, and CAPA systems.
  • Lead quality systems and compliance improvement, which result from Internal / External Audits, Management Review and / or any other CAPA / NC system indicator.
  • Participates as a key member in both external and internal audits and is responsible for the local Document Control, Records Management, NC, and CAPA processes and directed inspections.
  • Represents the site and collaborates with business partners as the CAPA Site Leader.
  • Facilitates (or delegates Facilitation) and leads the site CAPA Review Board / Data Review Board / Quality Metrics Review / Management Review.
  • Partner with management to develop and implement meaningful trending of Change Management, NC and CAPA performance.
  • Leverage Process Excellence tools to effectively implement CAPA using a DMAIC approach. -
  • Responsible to mentor both technical and non-technical resources in investigation, troubleshooting, escalation, and resolution of product and process quality issues, NC and CAPA.
  • Supports the continuous improvement of the Document Control, Records Management, CAPA and NC processes and electronic system for managing CAPA and NCs. -
  • Responsible for ensuring personnel and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
  • Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
  • 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
  • Performs other duties assigned as needed Qualifications Required:
    • University/Bachelors Degree or Equivalent
    • 8 - 10 years of work experience
    • Experience leading NCs and CAPAs.
    • Experience in Change Management and Document Control.
    • Experience in Records Management.
    • Knowledge of regulatory requirements (ISO, QSR, etc.).
    • Experience with external auditing bodies.
    • Demonstrated project management skills with strong results orientation
    • Strong communication, influencing and presentation skills Preferred:
      • Process Excellence Green Belt Certification with demonstrated problem-solving and statistics skills At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work. 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. For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com . Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor 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.andEqual Employment Opportunity Posters GINA Supplement. If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance This site is governed solely by applicable U.S. laws and governmental regulations. Please see our. Use of this site constitutes your consent to application of such laws and regulations and to our. Your use of the information on this site is subject to the terms of our. You should view thesection and the most recent SEC Filings in thesection in order to receive the most current information made available by Johnson & Johnson Services,Inc.with any questions or search this site for more information.Privacy Policy Privacy Policy Legal Notice News Investor Contact Us

Keywords: Johnson & Johnson, Irving , Quality Systems Lead, Other , Irving, Texas

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