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Director of Quality Systems

Company: Orthofix Holdings, Inc.
Location: Lewisville
Posted on: March 13, 2023

Job Description:

Why Orthofix? - - -Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. -At Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun! -As an Orthofix employee, you will become an integral part of our culture by continually demonstrating the highest level of integrity and our beliefs while making an impact to our vision "To be a highly respected global orthopedic and spine company that delivers exceptional value to our patients, customers, team members, partners and shareholders."Director of Quality SystemsHow you'll make a difference?Establish and maintain a Quality System in compliance with FDA, QSR, MDD and ISO regulations. - Responsible for the successful completion of individual projects as well as the projects of subordinates. - Responsible for establishing the strategic goals of the quality system in conjunction with senior management. -What will your duties and responsibilities be?Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

  • Responsible for the implementation and reporting of the performance of the Quality Management System to the executive management team.
  • Responsible for the internal and supplier audit program.
  • Responsible for Supplier Quality management.
  • Maintain current knowledge of European, Federal, and State regulations regarding design and manufacturing of medical devices.
  • Hire, train, and manage Quality and Document Control Staff. - -
  • Responsible for the company training system.
  • Generates and maintains procedures needed to meet regulatory requirements and business needs.
  • Interfaces with regulatory bodies (FDA, State FDB, and Notified Body) during external audits of the quality system.
  • Proactively champion quality assurance issues where applicable in company-wide activities.
  • Conducts regular employee training in QSR and ISO regulations. -
  • Responsible for the environmental controls.
  • Responsible for the calibration and maintenance program.
  • Responsible for the Document Control System.
  • Plan, schedule, and complete projects in a manner consistent with corporate objectives.
  • Regularly make presentations to the Design Review group and executive management team regarding project status.
  • Develops and administers the department budgets, schedules, and other administrative functions. -
  • Procure and oversee outside vendors and consultants as required. -
  • Support company goals and objectives, policies and procedures, QSR, and FDA regulations.
  • Designated Management Representative for the Quality System.What skills and experience will you need?
    • BS in life sciences, engineering, or equivalent is preferred.
    • Minimum fifteen (15) years related experience in the medical device industry in addition to a minimum ten (10) years of supervisory experience. -
    • Possess a thorough working knowledge of ISO 13485, 21 CFR 820, MDD and CMDCAS, as well as, familiarity with Australian and Brazilian regulations. -
    • Excellent written and verbal communications and time management skills required.What will the physical demands work conditions be like?The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.---
      • The ability to use a computer and required software programs. -
      • May be required to sit for extended periods of time. -
      • Requires normal ambulatory skills to move from one place to another within and outside the building.Orthofix complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Orthofix makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Orthofix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Keywords: Orthofix Holdings, Inc., Lewisville , Director of Quality Systems, Executive , Lewisville, Texas

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