Product Complaints Analyst 2

Overview

Cross-functional Quality role responsible for processing complaints related to on-market medical devices as part of Illumina's Quality Complaint Handling Unit.

What you'll do

• 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.
• Participate in complaint handling activities, such as complaint record review and closure, and in escalated complaint investigation as needed.
• Document and evaluate complaints and facilitate cross-functional discussions with SMEs.
• Complete other activities as assigned.

What you'll need

• Bachelor's degree in an engineering or science discipline.
• Minimum 2 years' experience in complaint handling or direct experience working in the medical device / in-vitro diagnostics (IVD) industry.
• Good Documentation Practice (GDP) experience.
• Familiarity with quality regulations and standards (21CFR820, ISO 13485, ISO 14971, and/or IVDR).
• 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).

Nice to have

• Advanced degree.
• Quality certification (e.g., CQA, CQE).
• Knowledge and/or experience using an Electronic Quality Management System for complaint handling.

Details

• Location: Bengaluru, India (Manyata).
• Shift work to support the US region; no night shift required.
• Not eligible for visa sponsorship.