Senior Director Global Product Quality
Company: Integra Lifesciences
Posted on: June 24, 2022
Senior Director, Quality Assurance and Compliance - TT Division
Vacancy ID 2021-40253 Location US-NJ-Princeton Position Type
Regular Full-Time Category Quality Assurance Overview Integra
LifeSciencesis a global leader in regenerative technologies and
neurosurgical solutions dedicated to limiting uncertainty for
clinicians, so they can focus on providing the best patient care.
Founded 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.
But 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
ours. At 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 success. Integra's 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. Regardless
of geographic location, our commitment is to offer the following,
- Benefit plans that meet all local statutory requirements
- A range of programs that reflect typical local market
- An opportunity for employees to tailor benefits to their
- Benefits that balance employee's short-term and long-term needs
Click HERE for more information regarding our benefits and total
rewards program Responsibilities Directs, coordinates and evaluates
the activities of employees in the Quality Department, including
Quality Assurance, Quality Engineering and Quality Control. These
activities include the development, implementation, and monitoring
of quality programs and policies that ensure the development,
manufacture and distribution of medical devices in compliance with
corporate policies, U.S. Food and Drug Administration regulations,
ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU
Medical Device Regulation, Japanese Pharmaceutical Affairs Law,
Anvisa, TGA and AATB, ISO 2242 and other applicable regulatory
- Directly supervises employees in the Quality Department.
Carries out supervisory responsibilities in accordance with the
organization's policies and applicable laws. Responsibilities
include interviewing, hiring and training employees; planning,
assigning and directing work; appraising performance; rewarding and
disciplining employees; addressing complaints and resolving
- Builds high performance cultures and teams, empowering and
holding direct reports and cross-functional teams accountable for
successful implementation and execution of CAPAs, continuous
improvement initiatives, and other quality initiatives
- Provides strategic direction and communication of the company's
goals, directives and policies to subordinates, creating a clear
vision and positive, team-oriented environment resulting in the
achievement of the company's goals and increased
- Oversees TT manufacturing quality and drives standardization &
consistency across the Division
- Ensure dependable and timely results from quality control,
including process control and support for process changes in
compliance with QSR, ISO and other regulatory requirements.
- Ensure and improve product reliability through proven quality
science. Post market surveillance, CAPA, Complaints, reduction of
- Oversee product quality reviews, divisional management reviews
and preparation of quality reports as applicable for various
forums, Divisional Board Review (DBR), Plant Operational reviews
- Direct the activities of the Quality Department to ensure
compliance with all appropriate regulations and standards,
including FDA, ISO 13485, CMDR, MDR and JPAL.
- Ensures site compliance and readiness. Oversees external
regulatory inspections, timely follow up and closure of Regulatory
- Interact and coordinate activities with other departments,
external vendors and customers. Influences and collaborates across
stakeholder groups in the areas of process / continuous
improvements, identify and implement opportunities.
- Ensure that all projects and validations are in compliance with
QSR, ISO and other regulatory requirements.
- Participate in evaluation of new product opportunities
(introductions, enhancements, obsolescence).
- Maintain fiscal responsibility and budget compliance.
- Perform other related duties as expected. Qualifications The
requirements listed below are representative of the knowledge,
skill, and/or ability required for this position.
- High educational background/Master in a scientific discipline
required with min 15 years experience in the medical device or
pharmaceutical industry and minimum 7 years of people management
- Strong analytical skills, exceptional writing and interpersonal
relationship skills or a combination of relevant work experience
- Significant area of expertise developed through experience and
positive track record.
- Demonstrated knowledge of FDA regulations, ISO 13485, CMDR,
Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and
other national and international regulations and standards.
- Experience with direct contact with FDA and EU Notified
- Knowledge of process design and implementation, change control,
auditing, and document management systems.
- General knowledge of statistical analysis.
- Demonstrated organizational, management and communication
- Must be able to read and write in English. Must be able to
demonstrate comprehension of written English by successfully
completing unassisted written tests, including, but not limited to,
Work Instructions and Standard Operating Procedures.
- Ability to travel up to 30% or more if needed base on site
needs. In an effort to minimize the spread of the coronavirus and
to protect our employees, all new hires in the US and Puerto Rico
will need to be fully vaccinated for COVID-19 in order to be
considered for employment with Integra LifeSciences, unless
eligible for an accommodation as provided by law. Sorry the Share
function is not working properly at this moment. Please refresh the
page and try again later.
Keywords: Integra Lifesciences, Trenton , Senior Director Global Product Quality, Executive , Princeton, New Jersey
Didn't find what you're looking for? Search again!