Product Complaints Analyst 2
On-siteBengaluru, Karnataka, India
Job Summary
Conduct review of complaints for regulated products in a timely manner, documenting, evaluating, and facilitating cross-functional discussions with subject matter experts. Identify, triage potential adverse events and field actions, and escalate to the QA Complaint leadership team as needed. Participate in monitoring the QA Complaint Handling inbox, performing rotational "monitor" activities, and ensuring adequacy and accuracy of complaint records. Support Global complaints for case handling audits when necessary. Complete other activities as assigned. Willingness to work in shifts to support the US region (no night shift required).
Required Qualifications
- Bachelor's degree in an engineering or science discipline
- Minimum 2 years' experience in complaint handling or direct experience working in medical device / in-vitro diagnostics (IVD) industry
- Good Documentation Practice (GDP) experience
- Familiar with quality regulations and standards (21CFR820, ISO 13485, ISO 14971, and/or IVDR)
- 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
Desired Qualifications
- advanced degree
- Quality Certification (e.g., CQA, CQE)
- Experience using Electronic Quality Management System for Complaint Handling
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.