Surveillance Engineer

Highly Competitive Salary
  1. Permanent
  2. Manufacturing, Design, Project Management
  3. United States
Atlanta, USA
Posting date: 07 Aug 2020
EN.BC.31123D

Proclinical is currently recruiting for a Post-Market Surveillance Engineer with a pharmaceutical company located in Atlanta, GA. The candidate will support technical investigational review activities for device and combination products in support of the Post Market Surveillance Program.

Job Responsibilities:

  • Support the implementation of a Post Market Surveillance Program into the Quality Management System.
  • Participates in periodic reviews related to clinical and commercial device and combination product investigation outcomes.
  • Partner with risk management to ensure Post Market Surveillance requirements are met.
  • Perform data analytics on the global complaint data in order to support trend analysis and determine further actions or ad-hoc risk assessments to be performed.

Skills and Requirements:

  • Bachelor's Degree, in Sciences or Engineering (Biomedical, Mechanical)
  • Minimum of 3 years of experience in medical devices or related industry with a concentration in Post Market Surveillance, Global Combination Product Relations, reliability and risk assessment.
  • Previous working experience in a medical device manufacturing environment desired.
  • Knowledge of the regulatory and compliance requirements of device design controls and combination products (i.e. FDA QSR 21 CFR Part 4 and 820 / ISO13485 quality system requirements).

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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