Surveillance Engineer job in Chicago, USA

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Job type: Permanent

Discipline: Manufacturing, Design, Project Management

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Post-Market Surveillance Engineer with a pharmaceutical company located in Chicago, IL. 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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