Product Complaints Analyst 2

Job Summary

In this cross functional Quality role, the Product Complaint Analyst 2 will be responsible for processing complaints related to on-market medical devices. Participate in complaint handling activities, such as complaint record review and closure and participate in escalated complaint investigation, as needed, as part of Illumina's Quality Complaint Handling Unit.

This position is responsible for processing complaints which includes, documenting, evaluating and facilitating cross functional discussions with SMEs and ensuring that customer feedback is appropriately evaluated. Provide colleagues support as needed.

Responsibilities

• Conduct review of complaints for regulated products in a timely manner.
• Identify, and triage potential adverse events and/or field actions and escalate to the QA Complaint leadership team in a timely manner.
• Participate in monitoring the QA Complaint Handling inbox and conduct tasks associated with rotational monitor activities.
• Ensure adequacy and accuracy of complaint records.
• Support Global complaints for case handling audits, when necessary.
• Complete other activities as assigned.

All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

Education

• Bachelor's degree in an engineering or science discipline desired; advanced degree preferred.

Experience

• Minimum 2 years experience in complaint handling or direct experience working in medical device / in-vitro diagnostics (IVD) industry preferred.
• Knowledge and/or experience using Electronic Quality Management System for Complaint Handling is preferred.
• Good Documentation Practice (GDP) experience.
• Familiar with quality regulations and standards (21CFR820, ISO 13485, ISO 14971, and/or IVDR).

Skills

• Use of Microsoft Office Products and standard office tools.
• Ability to multi-task in a fast-paced environment and manage changing priorities with a high degree of self-motivation.
• Good written, oral, and interpersonal English communication skills.
• Willingness to work in shifts to support the US region (No night shift required).

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.