Director of Quality
Company: Harmar Mobility LLC
Location: Kansas City
Posted on: April 9, 2021
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Job Description:
Looking for a new opportunity where your contributions are
valued? Somewhere where you can make an impact? Consider Harmar
Mobility LLC. Who is Harmar? We manufacture wheelchair lifts for
automobiles, stair lifts for the home, and residential and
commercial vertical platform lifts. We sell to dealers and to the
government. Ultimately our products give people access to their
homes and allow them to become more mobile. Our purpose and reason
for existence is helping people. The way we say that is We Lift
Lives.
This Director of Quality role is an important one for us. We are
looking for someone who has done this before preferably with a
medical device company and is experienced with FDA regulations.
Someone who understands how to build processes that work and can
help us reach new heights in terms of quality performance. It is
responsible for all our quality operations at 2 facilities, one
outside of Kansas City, MO, and the other in Sarasota FL. You will
be responsible for the design, implementation and proliferation of
the Harmar Quality Management System. Sound interesting? Read
on:
Essential Functions:
Work with executive staff in quality planning, driving diagnosis of
quality problems, corrective and preventive action programs and
maintaining the quality system.
Responsible for FDA / GMP compliance
Participate in design control, including quality planning, FMEA,
risk analysis, design reviews, and packaging.
Identify nonconformance trends and develop and administer technical
investigation and corrective action programs to resolve recurring
quality problems and to improve supplier quality.
Utilize standard statistical analysis techniques to determine
product acceptance, evaluate process capabilities, and develop
statistically sound tolerance limits based on product
specifications.
Interface with suppliers to assure quality and reliability of the
design during transfer to manufacturing, including overseeing and
support of quality programs and/or issues at the supplier's
site.
Provide technical guidance and training to other team members in
statistical analysis techniques, experimental design, data
analysis, sampling techniques and other QA Engineering areas of
expertise.
Assist manufacturing in improving with inspection, quality system
requirements, and process validation.
Lead internal and external quality related audit programs.
Represent Quality during product development and design
reviews.
Qualifications
Education/Experience:
B.S. Engineering or related field.
Minimum 10 years of Quality leadership experience, preferably in an
FDA or highly regulated environment.
Experience designing, implementing, and sustaining a Quality
Management System in accordance with 21CFR820 and ISO13485.
Technical Skills/Requirements:
Experience in developing and executing a successful Quality
strategy
Superior business leadership skills and acumen along with a
demonstrated ability to weigh the financial needs of the business
with the investments necessary to achieve the quality goals of the
business.
Experience leading the Quality function in a multi-site
manufacturing organization.
Experience and familiarity with modern Quality Assurance techniques
including Advanced Product Quality Planning (APQP), Production Part
Approval Process (PPAP) and Design for Six Sigma (DFSS).
Excellent project management skills and the ability to organize and
manage multiple priorities.
Travel:
Willing and able to travel up to 25% of the time.
PI132602742
Keywords: Harmar Mobility LLC, Kansas City , Director of Quality, Executive , Kansas City, Kansas
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