Compliance Specialist

Company: Integra LifeSciences
Location: Cincinnati
Posted on: July 23, 2021

Job Description:

Integra 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 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, whenever possible:

• Benefit plans that meet all local statutory requirements
• A range of programs that reflect typical local market practices
• An opportunity for employees to tailor benefits to their specific needs
• Benefits that balance employee’s short-term and long-term needs

Click HERE for more information regarding our benefits and total rewards program

ESSENTIAL DUTIES AND RESPONSIBILITIES

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 Coordinator.
• Assist or lead in the identification and implementation of CAPA.
• Assist or lead CAPA process activities (e.g., schedule and support CAPA Review Board meetings).
• Ensure compliance with cGMP, QSR, ISO13485, MDD/EU MDR, and other applicable regulations/standards.
• Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.
• Identify and implement opportunities for continuous improvement.
• Collection and reporting of metrics and data as required.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Education & Experience:

• BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 3-5 years of working experience in Quality Assurance/Control.
• Minimum of two years’ experience in a regulated industry, preferably Medical Device Industry
• Experience with CAPA processes (e.g., complaints, nonconforming product) and root cause investigation techniques (e.g., 5 why, fishbone, is/is not).
• Knowledge of medical device regulations (including FDA QSRs, ISO13485).
• Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).
• Knowledge of statistical sampling and analysis.
• Ability to communicate effectively (both written and oral) using English (or local language).
• Familiar with the MS Office Suite, including Microsoft Visio and Project.
• Must be able to observe company policies and safety procedures at all times.
• Demonstrated ability to work cross-functionally in a team environment.
• 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