Product Complaints Analyst 2

Illuminz; Bengaluru; In loco; INR 900.000 - 1.300.000; Tempo pieno

Descrizione del lavoro

Illumina seeks a Product Complaint Analyst 2 to join its Quality Complaint Handling Unit in Bengaluru. You will process complaints on-market for medical devices, documenting evaluations and coordinating with SMEs to ensure customer feedback is properly assessed.

The role requires reviewing complaints, triaging adverse events, supporting audits, and maintaining accurate records. Collaboration with global teams and flexibility for shifts supporting the US region are expected.

Competenze

• Bachelor's degree in engineering or science; advanced degree preferred.
• Quality certification (CQA, CQE) is a plus.
• Experience in complaint handling in medical devices/IVD preferred.
• GDP knowledge and regulatory standards familiarity (21 CFR 820, ISO 13485, ISO 14971, IVDR) preferred.

Mansioni

• Review complaints for regulated products promptly.
• Triage potential adverse events and escalate to QA leadership when needed.
• Monitor the QA Complaint Handling inbox and participate in rotational monitoring tasks.
• Ensure accuracy and completeness of complaint records.
• Support global complaints for audits and case handling.
• Perform other assigned tasks as required.

Conoscenze

English communication

MS Office

Multi-tasking

Interpersonal skills

Formazione

Bachelor's degree in engineering or science

Quality certification (CQA/CQE)

Strumenti

Electronic Quality Management System (eQMS)

Descrizione del lavoro

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 elevate 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
• Quality Certification a plus (e.g., CQA, CQE)

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.