Product Surveillance Associate

Job Description

623696 Product Surveillance Associate

1-year contract

Sturtevant, WI

Job Description :

a. 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 employees 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 in a timely manner.

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.

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)

Summary

The Product Surveillance Specialist IV performs day-to-day tasks and provides technical data assessment of post-market events. This position plays an integral role in maintaining compliance with global regulations. The Product Surveillance Specialist IV works with moderate supervision and requires a high degree of interaction with customers, health care professionals, and Global company employees at all levels within the organization.

Key Responsibilities

• Field inquiries received by phone, electronic, or verbal correspondence and determine if it qualifies as a complaint; document reported issues according to applicable SOP(s).
• Provide technical support and remote troubleshooting guidance as needed.
• Review associated records and contact users and customers to collect information on treatment, product performance, and functionality.
• Conduct periodic follow-up to close complaints in a timely manner.
• Manage customer relationships and expectations during the course of the complaint investigation.
• Complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records, and ensuring proper approvals are obtained as part of closure.
• Develop solutions to a variety of basic problems.
• Support statistical analysis of complaint trends.
• Support training programs by completing assigned training in a timely manner.

Process Improvement Initiatives

Compliance Initiatives

Other Duties

Education / Professional Experience

Knowledge, Skills, and Abilities

Pay Rate : $22 / hr