- Location
- India - Bengaluru - Manyata
- Type
- Full-time
- Department
- IT
- Experience
- 2+ years
- Source
- Workday
Description
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.
