Quality Assurance Specialist for Medical Device Quality Systems

7 days ago


Plainsboro, New Jersey, United States Integra LifeSciences Full time

**Company Overview**

At Integra LifeSciences, we strive to create a positive impact on the lives of patients and healthcare professionals. Our mission is to deliver innovative solutions that advance patient outcomes and set new standards of care.

Salary: $80,000 - $120,000 per year

As a Quality Assurance Engineer II at Integra LifeSciences, you will play a critical role in ensuring the quality and compliance of our medical devices. Your primary responsibilities will include:

Job Description

  • Providing quality compliance support on all aspects of the Plainsboro, NJ CMC Quality System
  • Maintaining an accurate log of Non-Conformances and CAPAs activities, tracking and following up with teams to ensure timely closure
  • Providing hands-on guidance and training to personnel performing activities within the Quality system
  • Ensuring documentation is complete before closure
  • Assisting the Quality Systems team in investigating Nonconformances and implementing CAPAs
  • Presenting monthly and quarterly metrics to the Quality Review meetings
  • Maintaining a thorough understanding of relevant regulations, including FDA, ISO 9001, and ISO 13485
  • Interacting and coordinating activities with other departments, external vendors, and customers

Required Skills and Qualifications

  • Bachelor's Degree in Science (Biology, Chemistry) or Engineering (Biomedical, Mechanical, Chemical, or Electrical)
  • 3-6 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing
  • Demonstrated knowledge of investigations, root cause analysis, quality systems, the CAPA system, and technical writing
  • Excellent organizational and communication skills
  • Proficient with MS Office Suite and statistical software
  • Able to work independently with minimal supervision

Benefits

We offer a comprehensive benefits package, including health insurance, retirement plans, paid time off, and opportunities for professional growth and development.

Others

Integra LifeSciences is an equal opportunity employer committed to providing a diverse and inclusive work environment. If you are passionate about delivering high-quality products and making a difference in the lives of patients, join our team today



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