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Quality Engineer I.US-BOS.001

Employer
Integra LifeSciences
Location
South Boston, MA
Closing date
May 18, 2022

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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 requirementsA range of programs that reflect typical local market practicesAn opportunity for employees to tailor benefits to their specific needsBenefits that balance employee's short-term and long-term needsClick HERE for more information regarding our benefits and total rewards program

Responsibilities:
Assist with key Quality Engineering areas of responsibility, including, but not limited to:Identification and implementation of CAPAControl of Nonconforming Product process activities (e.g., MRB review/approval)Execution of Risk Management activitiesReview and approval of change orders (design and process)Supplier controls (e.g., SCARs, supplier audits)Identification of statistically based sampling plans for inspections and validationsValidations/Qualifications for new and existing products, processes and equipmentSupport Internal Audit program.Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.Identify and implement opportunities for continuous improvement.Collect and report metrics and data as required.Perform other duties as assigned by Team Leader.

Qualifications:
BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 1-3 years of working experience in Quality Assurance/Control. Some experience in Medical Device Industry is preferred.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).Understanding of CAPA processes including investigational techniques.Understanding of Risk Management regulations and application (ISO14971).Knowledge of statistical sampling and analysis.Ability to communicate effectively (both written and oral) using English (or local language).Demonstrated ability to work cross-functionally in a team environment.Ability to work independently with little supervision.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 values.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.
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