Senior Director, Quality
Company: Orthofix Holdings, Inc.
Posted on: February 22, 2021
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."Senior Director, QualityHow
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
- 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
- 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 ten (10) years related experience in the medical device
industry in addition to a minimum five (5) years of supervisory
- Possess a thorough working knowledge of ISO 13485, 21 CFR 820,
MDD and CMDCAS, as well as, familiarity with Australian and
- 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
- 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. Posted 15 Days Ago Full time OFX20250 About Us HEALING
BONES. HEALING LIVES Orthofix International began in a small
farmhouse in Verona Italy in 1980 when orthopedic researcher
Giovanni De Bastiani recognized the bone's natural repair
capability, a concept he called "dynamization" and with that in
mind, he created the first external fixation device. Today,
Orthofix has grown to more than 900 employees with locations in the
U.S., Italy, Germany, France, the UK, Brazil, Australia and Puerto
Rico. Our products help patients in 70 countries around the world.
Orthofix is comprised of four strategic business units; Biostim,
Biologics, Extremity Fixation and Spine Fixation. Our products are
widely distributed via the company's sales representatives,
distributors and subsidiaries. At Orthofix we are committed to
clinical research and driven by new product introductions. We are
proud of our strong partnerships with organizations such as the
Texas Scottish Rite Hospital for Children in Dallas and the
Musculoskeletal Transplant Foundation. We take pride in developing
superior products and providing world class education for surgeons
and field-based Orthofix personnel supporting them around the
world. Orthofix makes a difference in the lives of our patients by
providing our surgeon customers with innovative medical devices to
meet the needs of their patients. Every day we are optimizing our
operations, improving efficiencies and examining our systems to
provide the best support possible to our representatives, surgeons
Keywords: Orthofix Holdings, Inc., Lewisville , Senior Director, Quality, Executive , Lewisville, Texas
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