Quality Engineer II, Post Market Surveillance Specialist
4 weeks ago
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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