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Director, Design Assurance

Company: Orthofix Holdings, Inc.
Location: Lewisville
Posted on: January 23, 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, Design AssuranceHow you'll make a difference? -The Director of Design Assurance leads a team of Quality Engineers and Technicians in direct support of product development; responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management in the development process. The Director of Design Assurance is a key partner to the Research & Development, Regulatory and Marketing teams in achieving new product development and commercialization.What will be your Duties and Responsibilities?Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

  • Maintain oversight over all design quality operations to assure full compliance with applicable laws, regulations and policies.
  • Oversee product and manufacturing changes for potential impact on future and current applications.
  • Assure consistency and quality of device testing and compliance, through technical guidance to staff during the course of strategy formulation and actual testing.
  • Establish departmental priorities and implement through direct supervision of staff, ensuring timely completion of activities in support of company goals.
  • Advise management group of prevailing and evolving product compliance issues
  • Foster employee career development, and actively participate in trade and professional organizations
  • Owns and drives deliverables through design assurance staff related to Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives.
  • Develops and implements quality strategies for new product development to attain quality goals.What Skills you'll need?
    • 8 + Years of Experience in:
    • Design engineering in medical device industry and related areas, e.g. R&D &/or Manufacturing
    • Quality Assurance and/or Quality Engineering, including Quality systems, standards, metrics, and tools desirable
    • Canadian Medical Device Regulations (CMDR); EU Medical Device Directive (EU MDD 93/42 EEC), EU Medical Device Regulation, ISO 13485, and ISO 14971 a plus.
    • BS or BA degree, experience with medical devices, Quality System Regulations, ISO 9001 / ISO 13485, CE marking of devices, and quality assuranceWhat Supervisory Responsibilities will you have?
      • Provides guidance and training to staff, assists subordinates in attaining career goals, to include motivating individuals in achieve results.
      • Recruits and maintains a high qualified staff and foster employee career development, and actively participate in trade and professional organizations
      • Must foster collaboration with cross functional teams.What will the Physical Demands and Work Conditions be like?
        • Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 50 lbs.
        • Eyesight and hearing must be correctable to standard level.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, Design Assurance, Executive , Lewisville, Texas

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