Specialist, Commercial Quality Assurance

Key Responsibilities

Post-Market Surveillance

Manage field actions, recalls, and adverse event reporting. Coordinate internal communication, maintain customer databases, and communicate with end customers within defined timelines as per Beckman procedures.

Supplier Management

Conduct supplier category assessments, review supplier documentation, onboard suppliers into SharePoint, and perform annual supplier performance reviews.

Audit Management

Plan, prepare, and conduct internal audits as well as supplier and sales channel partner audits. Prepare audit reports and track findings to ensure closure and compliance.

Non-Conformance & CAPA Management

Classify non-conformances (high, medium, low) and ensure timely closure in SmartSolve. Manage corrective and preventive actions (CAPA), including fast-track CAPAs, within defined timelines.

Regulatory & Compliance Support (Preferred)

Support regulatory activities, including handling import licenses, retention, and post-approval change submissions for medical devices.

Continuous Improvement & Documentation

Implement continuous improvement initiatives and maintain accurate records in compliance with QMS and company policies.