Sr Manager, Quality Engineering
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
Management of Quality Engineering areas of responsibility,
Complaint Investigations/ AER/Recall Support (HIA/HHE)
Control of NC Product/MRB/Product disposition approvals
Product Holds – Initiation and Release
CAPA support of investigations
Risk Management support
Change Control (design & process) - DCR/ECR approvals
Inspection Plan Development
EU MDR Support
Management and mentoring of Quality Engineering
Quality Engineering representative during Management Reviews and
audits (internal and external).
Other Quality Engineering areas as assigned by Director of QA
- Bachelor’s degree in Quality
Assurance or Engineering or related discipline.
- Five to ten (5-10) years’ of
experience in Quality Engineering in the Medical Device
- Experience in personnel
management and mentoring.
- Demonstrated experience in
successfully leading a team.
- Experience in project
- Experience with statistical
- Working knowledge of QA
Engineering related QMS elements including Design Controls,
Production and Process Controls (including Process Validation),
Control of Nonconforming Product, Facilities/Environmental
Controls, Labeling and Packaging Controls, Handling, Storage,
Packaging and Distribution of Product, Inspection and Test, Test
- Experience with CAPA processes
including investigational techniques.
- Experience with Risk
Management regulations and application (ISO14971).
- Working knowledge of medical
device regulations (including FDA QSRs, ISO13485).
- Strong technical aptitude
(i.e., able to read and comprehend technical documentation, ability
to comprehend and execute procedures, demonstrated understanding of
- Ability to interface with top
organizational leadership and internal and external customers,
responding in a professional manner.
- Ability to communicate
effectively (both written and oral) using English (or local
- Ability to influence positive
- Experience with development
and implementation of quality system procedures.
- Experience with tissue
- Experience with Cleanroom
environment and requirements preferred.
- Certified Quality Engineer
(e.g., ASQ CQE) preferred.
Keywords: Integra LifeSciences, Boston , Sr Manager, Quality Engineering, Other , Boston, Massachusetts
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