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
this job successfully, an individual must be able to
oversee/perform each essential duty satisfactorily. Other duties
may be assigned.
- Management of Document Control/Quality Records
processes and personnel.
Management of Internal Audit Program
and audit team.
Management of central CAPA process,
including coordination of CAPA Review Board (CRB).
Management of site Training
Quality Management Review
Coordination and preparation.
Quality Plan project management to
ensure timely completion.
Alternate site Quality Management
Leadership role (e.g., Backroom
Manager) during site audits/inspections.
Other QA/Compliance activities as
assigned by QA Site Leader.
Reloction and Free On-site parking is provided
requirements listed below are representative of the knowledge,
skill, and/or ability required for this position.
Education & Experience:
- Bachelor’s degree in Quality Assurance or
related discipline or 5-7 years’ experience in QA/Compliance within
the Medical Device Industry.
Extensive experience with
development and implementation of QMS.
Expert knowledge of medical device
regulations (including FDA QSRs, ISO13485).
Experience with FDA and/or Notified
Experience with Document Control and
Records Control processes.
Experience with CAPA processes
including investigational techniques.
Experience with Training program
Experience conducting QMS/Quality
Experience with coordination of
Quality Management Reviews.
Audit Experience, Auditor
Demonstrated experience in
successfully leading a team.
Ability to interface with top
organizational leadership in an effective manner.
Ability to communicate effectively
(both written and oral) using English (or local
Demonstrated ability to work
cross-functionally in a team environment.
Ability to work independently with
Familiar with the MS Office Suite,
including Microsoft Visio and Project.
Must be able to observe company
policies and safety procedures at all times.
Must be able to treat others with
respect; work with integrity and ethically; uphold organizational