Director of Quality Systems
Company: Orthofix Holdings, Inc.
Posted on: January 27, 2023
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
- 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
- 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
- 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
- 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
- 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
Keywords: Orthofix Holdings, Inc., Lewisville , Director of Quality Systems, Executive , Lewisville, Texas
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