Quality Assurance Specialist, Complaint Handling

Summary

• Participate in product quality activities, for complaint investigations of company products.
• Facilitates cross functional discussions in identifying, documenting, analyzing and reporting quality issues and ensuring that customer feedback is appropriately evaluated.
• Facilitate functional area initiatives as needed.
• Provide colleagues support as needed.

Key Responsibilities

• Reviews individual cases, assess for potential adverse events for escalation to Regulatory in a timely manner
• Reviews individual for the evaluation of complaints, including assessment, investigation, containment, for determination of escalation
• Ensures adequacy of complaint records to GMP Standards (e.g. investigations, CAPA, NCs)
• Participates and conducts tasks associated with rotational “monitor” activities of Quality Assurance escalation mailbox
• Facilitates the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs
• Participates, facilitates, and/or supports complaint investigations and resulting CAPA activities
• Completes other activities as assigned

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Qualifications Minimum Requirements

• Bachelor's Degree
• 2-5 years recent experience in Quality/Regulatory Affairs in a in vitro diagnostics device or medical device company