Job title: Complaint Analyst
About Us
Vaisesika is an ISO 27001 certified innovative and value driven company in the business of Software Development, Quality Engineering, Validated Testing, ERP services, Cloud Migration & DevOps, RPA, Data Analytics & Business Intelligence. We have offices in USA, Canada, India and UAE. We have been able to work in multiple projects in various domains ranging from Healthcare & Lifesciences, BFSI, e-commerce, Retail and we pride ourselves as one of the industry leaders in these areas.
Responsibilities
Ø Assess complaints, assign failure modes, and determine escalation needs for Potential Adverse Events (PAEs).
Ø Escalate PAEs to Clinical Specialists or PMS Manager as appropriate.
Ø Test returned units from reported complaints and ensure investigations are thorough.
Ø Close complaints in a timely manner while supporting KPI achievement and compliance with QMS procedures.
Ø Support Post-Market Surveillance (PMS) projects, including communication with OEMs/CMs and complaint data submission to vendors.
Ø Apply risk-based tools such as FMEA and Fault Tree Analysis (FTA) to guide decision-making and ensure equipment calibration and preventive maintenance compliance.
Ø Support investigations including OOTs, NCEs, CAPAs, and IACAs, ensuring regulatory compliance and timely execution.
Ø Bachelor’s degree in engineering or related technical field (or equivalent technical certification of ≥350 hours).
Ø Demonstrated problem-solving, decision-making, planning, and organizational agility skills.
Ø Strong communication and listening abilities, including cross-functional collaboration.
Ø Knowledge of FDA regulations, ISO 13485, ISO 14947, EU MDD/MDR, and AAMI standards.
Ø Experience or familiarity with laboratory practices, equipment qualification, and test method/procedure development.
Ø Statistical analysis skills for interpreting post-market data trends.
Ø Bilingual in Spanish and English (advanced level) preferred; proficiency in Microsoft Office, Minitab, Oracle, Agile, and H1.
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