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Product Surveillance Associate

Info Way Solutions LLC

Sturtevant, WI

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JOB DETAILS
SKILLS
Clinical Assessment, Customer Relations, Healthcare, Identify Issues, Inventory Management, Manufacturing Analysis, Market Analysis, Marketing, Pharmacovigilance, Physical Science, Problem Solving Skills, Purchasing/Procurement, Quality Assurance, Regulatory Compliance, SAP, Standard Operating Procedures (SOP), Surveillance, Technical Support, Technical Writing, Time Management, Writing Skills
LOCATION
Sturtevant, WI
POSTED
2 days ago

Job description:
Summary:
The Product Surveillance Associate position provides clinical and safety assessments of post-market events. This position is an integral role in marketing compliance with global regulations.
Job responsibilities:
  • Work with minimal supervision and requires a high degree of interaction with customers, health care professionals, and Global Merz at all levels within the organization.
  • Processing product complaint reports received by phone, electronic, or verbal correspondence in accordance with applicable SOP(s).
  • Provide technical support and remote troubleshooting guidance as needed.
  • Conduct follow-up activities to be able to close complaint records on time.
  • Complete complaint 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.
  • Process product replacement orders, create device service orders, and/or utilize the company's inventory management system as applicable. SAP experience is preferred.
  • Execute the activities of processing complaints in accordance with the Company Quality System.
Skills and Experience:
  • 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).
Work Location: 13900 Grandview Parkway, Sturtevant, WI

About the Company

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Info Way Solutions LLC

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