Director, Design Assurance
Company: Orthofix Holdings, Inc.
Posted on: January 23, 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, 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
- 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
- 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
- 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
- Provides guidance and training to staff, assists subordinates
in attaining career goals, to include motivating individuals in
- Recruits and maintains a high qualified staff and foster
employee career development, and actively participate in trade and
- 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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