Product Surveillance Associate - Medical Devices

Job Description

Title : Product Surveillance Associate - Medical Devices

Location : Sturtevant, WI

Duration : 12-month contract

The Product Surveillance Associate position provides clinical and safety assessments of post-marketing events. This position is an integral role in marketing compliance with global regulations.

Work with minimal supervision and requires a high degree of interaction with customers, health care professionals, and Global partners at all levels within the organization.

Processing the field inquiries received by phone, electronic or verbal correspondence in accordance to applicable SOP(s).

Provide technical support and remote troubleshooting guidance as needed.

Conduct follow-up activities to be able to close records on time.

Complete investigations, which may include execution of product returns and subsequent evaluations, reviews of manufacturing records, and assuring proper approvals are obtained as part of closures.

Execute the activities of processing complaints in accordance with the Company Quality System.

REQUIRED

BS in a Physical Science or Engineering or Equivalent Experience Required

Experience in Quality Assurance and / or other regulated industry or similar experience required

Strong technical writing and general problem-solving skills required

Requires Vision Assessment (20 / 20 near visual acuity & acceptable color vision)