Product Complaints Analyst

Illumina India Biotechnology Private Limited; Bengaluru; Presencial; INR 800.000 - 1.200.000; Jornada completa

Descripción de la vacante

Illumina India Biotechnology Private Limited seeks a Product Complaints Analyst 2 to join the Quality group. The role processes on-market medical device complaints, documents findings, and participates in escalation discussions with SMEs to ensure customer feedback is properly evaluated.

The position requires a bachelor’s degree in engineering or science, 2+ years in complaints or medical devices, GDP experience, and strong English communication with the ability to multitask in a fast-paced

Formación

• 2+ years in complaints handling or IVD/medical device industry
• GDP experience
• Knowledge of quality regulations and standards (21 CFR 820, ISO 13485, ISO 14971, IVDR)

Responsabilidades

• Review complaints for regulated products promptly
• Triage adverse events and escalations to QA leadership
• Monitor QA complaint inbox and perform rotate-monitor tasks
• Ensure accuracy and completeness of complaint records
• Support global complaints for audit readiness
• Perform additional tasks as assigned
• Essential functions may expand with business needs

Conocimientos

English communication

Multi-tasking

Interpersonal skills

Self-motivation

Educación

Bachelor’s degree in engineering or science

Advanced degree preferred

Quality Certification (CQA, CQE)

Herramientas

Electronic QMS

Descripción del empleo

Product Complaints Analyst 2 What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position 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 escalated 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).

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics.

We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race.

We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility.

We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Illumina conducts background checks on applicants for whom a conditional offer of employment has been made.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws.

Background check results may potentially result in the withdrawal of a conditional offer of employment.

The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws.

Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process.

If you require accommodation to complete the application or interview process, please contact [e-mail].

To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants.

This role is not eligible for visa sponsorship.