Quality Engineer II, Post Market Surveillance Specialist

4 weeks ago


Princeton, New Jersey, United States Integra LifeSciences Full time

Post Market Surveillance Quality Engineer Job Summary

Integra LifeSciences is seeking a highly skilled Post Market Surveillance Quality Engineer to join our team. As a Post Market Surveillance Quality Engineer, you will be responsible for ensuring the safety, quality, and performance of our medical devices throughout their lifetime.

Key Responsibilities:

  • Develop Periodic Safety Update Reports (PSURs) for Class II and Class III Medical Devices and Post Market Surveillance Reports (PMSRs) for Class I and non CE marked Medical Devices.
  • Collaborate with cross-functional teams to gather post market surveillance data and ensure compliance with Medical Device Regulations worldwide.
  • Utilize critical thinking to assess post market surveillance data and provide recommendations for outputs.
  • Act as a Post Market Surveillance Subject Matter Expert for Notified Body and Regulatory Body communications.
  • Facilitate and lead communications with stakeholders regarding Post Market Surveillance activities.

Requirements:

  • Bachelor's degree in a scientific discipline, preferably Biomedical Engineering or Nursing.
  • Minimum 3 years of experience in a Post Market Surveillance function within a fast-paced medical device company.
  • Strong analytical skills, exceptional writing and interpersonal relationship skills.
  • Demonstrated knowledge of FDA regulations 21 CFR 803, 820, ISO 9001, ISO 13485:2016, Medical Device Directive Regulation (93/42EEC), Medical Device Regulation (2017/745), MDSAP, and other national and international regulations and standards.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

How to Apply:

If you are a motivated and detail-oriented individual with a passion for quality and safety, please submit your application, including your resume and cover letter, to our website.



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