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Product Surveillance Associate

Product Surveillance Associate

Planet PharmaSturtevant, WI, US
Hace 23 horas
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

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

  • Support operational changes to improve efficiencies in all aspects of complaint handling.
  • Support investigations associated with product deviations, product non-conformances, CAPAs, scrap, and rework, and analyze data for quality improvement and reporting.

    • Compliance Initiatives

  • Support internal and external quality system audits.
  • Evaluate complaints and determine if submission of a Medical Device Report (MDR) or other Vigilance Report is required.

    • Other Duties

  • Follow any other job-related instructions and perform additional duties as required by supervisor.

    • Education / Professional Experience

  • High School Diploma with 3 years of experience, or Associate’s Degree with 1 year of experience — Required
  • Customer service experience — Preferred
  • Medical or surgical office experience — Preferred

    • Knowledge, Skills, and Abilities

  • Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and / or other international medical device regulations — Preferred
  • Basic medical and / or scientific terminology — Preferred
  • Organized with strong attention to detail — Required
  • Able to prioritize and manage multiple records / reports simultaneously — Required
  • Professional phone etiquette with the ability to appropriately handle sensitive information — Required
  • Good communication skills, both written and verbal — Required
  • Ability to work effectively with staff and communicate across the organization — Required
  • Experience with Microsoft Office Suite — Required

    • Pay Rate : $22 / hr

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