Illumina

Product Complaints Analyst 2

Posted 8 Hours Ago

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Bengaluru, Bengaluru Urban, Karnataka, IND

In-Office

Junior

Healthtech • Biotech

The Role

Processes and reviews complaints involving regulated medical devices and IVD products. Documents, evaluates, and ensures accurate complaint records; identifies and escalates potential adverse events and field actions; supports investigations, audits, inbox monitoring, and cross-functional collaboration with subject matter experts. The role requires familiarity with quality regulations, electronic quality management systems, Good Documentation Practice, and willingness to work shifts supporting the U.S. region.

Summary Generated by Built In

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 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

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 [email protected]. 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.

Skills Required

Bachelor's degree in an engineering or science discipline
Advanced degree
Minimum 2 years of experience in complaint handling or direct experience in the medical device or IVD industry
Quality certification such as CQA or CQE
Experience using an electronic quality management system for complaint handling
Good Documentation Practice experience
Familiarity with quality regulations and standards, including 21 CFR 820, ISO 13485, ISO 14971, and/or IVDR
Proficiency with Microsoft Office products and standard office tools
Ability to multitask, manage changing priorities, and work independently in a fast-paced environment
Strong written, oral, and interpersonal English communication skills
Willingness to work shifts supporting the U.S. region

Illumina Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Illumina and has not been reviewed or approved by Illumina.

Healthcare Strength — Health coverage includes comprehensive medical (HMO/PPO), dental, vision, mental health, life, and disability insurance with options such as FSAs/HSAs and wellness resources. Offerings are described as robust across regions with customization in certain locations.
Leave & Time Off Breadth — Time-off programs include flexible schedules and remote work, PTO or flexible time off, paid holidays and sick leave, and volunteer time. Company-wide shutdowns during summer and winter add additional paid time away.
Parental & Family Support — Family-focused programs include fertility assistance, adoption assistance, and reproductive health support alongside family medical leave. Paid parental leave is provided, with specifics varying by country and employment status.