Illumina is hiring for the Product Complaints Analyst 2 position in Bengaluru. This opportunity is suitable for science and engineering graduates with experience or knowledge in medical device complaint handling, quality assurance, IVD products, Good Documentation Practices (GDP), and quality management systems.
The Product Complaints Analyst 2 will join Illumina’s Quality Complaint Handling Unit and support complaint processing for regulated, on-market medical devices. The position involves complaint record review, evaluation, documentation, adverse event triage, escalation, and collaboration with subject matter experts.
Candidates looking for medical device quality assurance jobs in Bengaluru, product complaint handling jobs, or IVD quality jobs in India can consider this opportunity.
Key Responsibilities
As a Product Complaints Analyst 2 at Illumina, responsibilities include:
- Review complaints associated with regulated medical devices and products.
- Process and document product complaints accurately and within required timelines.
- Evaluate customer feedback and ensure appropriate complaint documentation.
- Identify and triage potential adverse events and field actions.
- Escalate potential safety or quality issues to the QA Complaint leadership team.
- Review complaint records for accuracy, adequacy, and completeness.
- Facilitate cross-functional discussions with relevant subject matter experts.
- Participate in escalated complaint investigations when required.
- Monitor the QA Complaint Handling inbox as part of rotational monitoring activities.
- Support global complaint case-handling audits when required.
- Maintain appropriate documentation according to applicable quality requirements.
- Perform additional quality and complaint-handling activities assigned by the organization.
Qualification & Eligibility
Candidates interested in the Illumina Product Complaints Analyst 2 job should preferably have:
- Bachelor’s degree in an Engineering or Science discipline.
- An advanced degree is preferred but not mandatory.
- Quality certifications such as Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) are an advantage.
- Minimum 2 years of experience in complaint handling or direct experience within the medical device or in-vitro diagnostics (IVD) industry is preferred.
- Experience with an Electronic Quality Management System (eQMS) for complaint handling is preferred.
- Experience with Good Documentation Practices (GDP).
- Familiarity with applicable medical device quality regulations and standards.
Relevant Regulatory Knowledge
Knowledge or familiarity with the following is valuable:
- 21 CFR Part 820
- ISO 13485
- ISO 14971
- IVDR
- Medical device complaint handling
- Quality Management Systems
- Adverse event identification and escalation
Skills Required
Illumina is looking for candidates with:
- Medical device complaint handling knowledge
- Product complaint review and documentation skills
- Good Documentation Practice (GDP)
- Quality assurance knowledge
- eQMS exposure
- Medical device / IVD industry knowledge
- Microsoft Office proficiency
- Strong written and verbal English communication
- Ability to manage multiple priorities
- Strong attention to detail
- Ability to work effectively in a fast-paced environment
- Cross-functional communication skills
Candidates should also be willing to work in shifts supporting the US region. According to the job description, no night shift is required.
Why Join Illumina?
Illumina works in genomic and healthcare technologies designed to advance disease detection, diagnosis, treatment development, and human health.
This role provides an opportunity to gain or expand experience in:
- Medical device quality assurance
- Global product complaint handling
- IVD quality processes
- Complaint investigations
- Adverse event triage
- Quality and regulatory compliance
- Cross-functional quality operations
The company also emphasizes an inclusive working environment, collaboration, employee development, and equal employment opportunities.
Who Should Apply?
This position may be particularly relevant for professionals with approximately two or more years of experience in areas such as:
Medical Device Quality Assurance, Product Complaint Handling, Post-Market Quality, IVD Quality, Complaint Investigation, Quality Management Systems, or related regulated medical device functions.
Fresh graduates should note that the job description states a minimum of 2 years of complaint handling or direct medical device/IVD industry experience is preferred, so experienced candidates are likely to be more competitive.
How to Apply
