Company: Integra LifeSciences
Posted on: July 23, 2021
LifeSciences is a global leader in regenerative technologies
and neurosurgical solutions dedicated to limiting uncertainty for
clinicians, so they can focus on providing the best patient
in 1989, Integra develops, manufactures, sells and supplies
best-in-class products to regenerate tissue, remove brain tumors,
prevent infection and much more. And over the last three decades,
we’ve evolved into one of the world’s leading global medical
technology companies with more than 4,000 dedicated employees who
deliver innovative medical technology solutions.
that’s just the beginning. Integra is growing at an
unprecedented rate. We’re at a moment in time where the experience
you’ll gain is more robust than the experience you bring. And we’re
out to invest in your future because it’s the best way to maximize
Integra, we firmly believe our people are our greatest asset and
the foundation of our success. Our comprehensive Global Total
Rewards program provides competitive compensation and benefits
designed to keep our people healthy, motivated and engaged.
Investing in our people through these programs is possible because
of Integra’s ongoing commitment to our values and our shared
health as a company begins with the well-being of our people.
Benefit programs vary by country, whether provided through
company-sponsored insurance and programs, through statutory
government programs, or a combination of both.
of geographic location, our commitment is to offer the following,
plans that meet all local statutory requirements
range of programs that reflect typical local market
opportunity for employees to tailor benefits to their specific
that balance employee’s short-term and long-term needs
HERE for more
information regarding our benefits and total rewards
ESSENTIAL DUTIES AND
To perform this job successfully, an individual
must be able to oversee/perform each essential duty
satisfactorily. Other duties
may be assigned.
- Assist or lead
CAPA activities (e.g., investigations) as CAPA
Assist or lead
in the identification and implementation of CAPA.
Assist or lead
CAPA process activities (e.g., schedule and support CAPA Review
compliance with cGMP, QSR, ISO13485, MDD/EU MDR, and other
FDA inspections, ISO Certification and surveillance audits and
implement opportunities for continuous improvement.
reporting of metrics and data as required.
requirements listed below are representative of the knowledge,
skill, and/or ability required for this position.
- BS degree in
Engineering, Math or Science (Biology, Chemistry, Physics,
Statistics, etc.) or 3-5 years of working experience in Quality
Minimum of two
years’ experience in a regulated industry, preferably Medical
CAPA processes (e.g., complaints, nonconforming product) and root
cause investigation techniques (e.g., 5 why, fishbone, is/is
medical device regulations (including FDA QSRs,
aptitude (i.e. able to read and comprehend technical documentation,
ability to comprehend and execute procedures, demonstrated
understanding of system documentation).
statistical sampling and analysis.
communicate effectively (both written and oral) using English (or
the MS Office Suite, including Microsoft Visio and
Must be able to
observe company policies and safety procedures at all
ability to work cross-functionally in a team
Must be able to
treat others with respect; work with integrity and ethically;
uphold organizational values.
Keywords: Integra LifeSciences, Cincinnati , Compliance Specialist, Other , Cincinnati, Ohio
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