Illumina is recruiting for the position of Product Complaints Analyst 2 in Bengaluru, Karnataka, India. The role focuses on medical device complaint handling, quality documentation, complaint record review, and the identification and escalation of potential adverse events and field actions.
Candidates with a bachelor’s degree in engineering or a science discipline and at least two years of experience in complaint handling or relevant medical device or in-vitro diagnostics (IVD) industry experience are encouraged to review the job requirements.
Job Details
| Particulars | Details |
|---|---|
| Company | Illumina |
| Job Role | Product Complaints Analyst 2 |
| Job Requisition ID | 43521-JOB |
| Location | Bengaluru, Manyata, India |
| Job Type | Full-time |
| Experience | Minimum 2 years |
| Qualification | Bachelor’s degree in engineering or a science discipline desired |
| Preferred Industry | Medical Devices / In-Vitro Diagnostics (IVD) |
| Visa Sponsorship | Not eligible |
Position: Product Complaints Analyst 2
The Product Complaints Analyst 2 will work within Illumina’s Quality Complaint Handling Unit to process complaints related to marketed medical devices. The position involves evaluating customer feedback, maintaining accurate complaint records, coordinating with subject matter experts (SMEs), and supporting complaint investigations and audits.
Key Responsibilities
- Review complaints related to regulated products and process them within the required timelines.
- Identify and triage potential adverse events and field actions, escalating them to the QA Complaint leadership team when necessary.
- Monitor the QA Complaint Handling inbox and perform assigned rotational monitoring activities.
- Ensure complaint records are accurate and complete.
- Participate in complaint record review, closure, and escalated complaint investigations as needed.
- Support global complaint case-handling audits when required.
- Facilitate cross-functional discussions to ensure customer feedback is appropriately evaluated.
- Complete other assigned activities and provide support to colleagues as needed.
Eligibility and Qualifications
Candidates should review the following educational and experience requirements:
- Educational Qualification: A bachelor’s degree in an engineering or science discipline is desired.
- Advanced Degree: Preferred.
- Work Experience: Minimum two years of experience in complaint handling or relevant experience in the medical device or IVD industry is preferred.
- Quality Certification: Certifications such as Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) are an advantage.
- Documentation: Experience with Good Documentation Practice (GDP) is required.
- Quality Systems: Familiarity with electronic Quality Management Systems (eQMS) for complaint handling is preferred.
- Regulatory Knowledge: Familiarity with 21 CFR 820, ISO 13485, ISO 14971, and/or IVDR.
Required Skills
- Proficiency in Microsoft Office products and standard office tools.
- Ability to manage multiple tasks in a fast-paced environment.
- Ability to adapt to changing priorities with strong self-motivation.
- Good written and verbal English communication skills.
- Strong interpersonal and cross-functional collaboration skills.
- Willingness to work in shifts supporting the US region; night shifts are not required.
