Senior Product Complaints Analyst
On-siteBengaluru, Karnataka, India
Job Summary
Conduct product complaint investigations, including assessment, containment, review, and approval, while tracking adverse events and escalating to Regulatory. Lead cross-functional discussions to identify, document, and analyze quality issues, ensuring customer feedback is appropriately evaluated. Facilitate CAPA activities, write and review quality documents for internal and external distribution, and provide training on complaint processes. Participate in audits, inspections, and rotational monitoring of QA mailboxes to ensure adequacy of records. Drive product and process improvements to reduce complaints and cost of poor quality, providing status updates and managing escalations.
Required Qualifications
- Bachelor's degree in an engineering or science discipline
- 5-7 years' experience in life sciences industry or research
- direct experience working in medical device / in-vitro diagnostics (IVD) industry
- Knowledge of quality regulations and standards (21CFR820, ISO 13485, ISO 14971, and/or IVDR)
- Exposure to complaint management, product development (design controls, risk analysis, validation) and post-market sustaining / maintenance (change controls, risk management, manufacturing quality, supplier management)
- Experience leading and/or managing cross-functional projects
- Willingness to work in shifts to support the US region
Desired Qualifications
- advanced degree
- Quality Certification (e.g., CQA, CQE)
- 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
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