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QA Specialist II, 2nd Shift (2pm-10:30pm)

Company: Integra LifeSciences
Location: Boston
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

The Quality Assurance Specialist II oversees requirements for continuing cGMP training to keep all employees aware of their responsibilities and changing requirements for cGMP compliance. Works collaboratively with Manufacturing, Engineering, Quality Control, and other functional experts to support all daily operational activities. Functions as an information source to various company departments when special and critical quality issues occur. Conducts internal audits of production facilities assuring company standards and product integrity are maintained. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with manager and functional experts on special department projects. Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system. Performs the essential duties and responsibilities as listed in section below.


  • Writes and revises operating procedures
  • Conducts training for staff at all levels as it relates to quality systems
  • Processes document change requests and training records
  • Compiles quality metrics for daily/weekly/monthly reporting and reports metrics to site management
  • Compiles information for Quality Management Review
  • Conducts inspections of materials
  • Reviews records for compliance such as inspection reports, test records, and Device History Records
  • Updates component, product, and documentation databases
  • Reviews validation/qualification reports for GMP and quality system compliance
  • Conducts complaint investigations
  • Conducts CAPA investigations, proposes corrective and preventative actions, and conducts verification and effectiveness reviews
  • Investigates and reviews Nonconforming Material reports and presents reports/metrics during periodic meetings
  • Evaluates supplier quality performance and conducts periodic evaluations of suppliers
  • Conducts internal audits
  • Participates in audits/inspections by customers and regulatory agencies and compiles corrective and preventative action responses
  • Other duties may be assigned as necessary

  • Associates Degree with related work experience is required. A Bachelor’s Degree is preferred.
  • A minimum of 4 years’ experience in a Quality/Regulatory Compliance environment.
  • Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.
  • Moderate computer competence, including experience with database and Microsoft Office.
  • Knowledge of QA terms, tools, and methodologies.


This role is based in our South Boston facility, with free garage parking! 


Keywords: Integra LifeSciences, Boston , QA Specialist II, 2nd Shift (2pm-10:30pm), Other , Boston, Massachusetts

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