Senior Quality Engineer

Overview

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

Responsibilities

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 in the identification and implementation of CAPA.
* Assist or lead Control of Nonconforming Product process activities (e.g., MRB review/approval).
* Assist with and implement service and repair quality processes.
* Facilitate the execution of Risk Management activities.
* Support new product development and production (e.g., Change Order review and approval).
* Provides support necessary for supplier controls, including but not limited to, supplier audits.
* Identify statistically based sampling plans for inspections and validations.
* Aid in the implementation SPC control system with Manufacturing and Quality Control.
* Support validations for new and existing products, processes and equipment.
* Establish and maintain Quality Management System procedures related to areas of responsibilities.
* 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.
* Performs other Quality Management System related duties as required.

Qualifications

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).
* 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.