Coordinate the effective assessment, documentation, escalation and completion of all medical device complaints registered by the customer support call center. This position requires technical capability and the ability to effectively communicate the results of an investigative analysis through written reports in the designated complaint management system.
- Review entries created in the customer relationship management software for medical device complaints.
- Investigate potential issues via interviews and document review.
- Operate in a regulated medical device environment in accordance with 21 CFR 820 and ISO 13485.
- Review Device History Files, Device Master Records and Device History Records for released products.
- Contribute to formal change control process.
- Assist with all CAPA activities.
- Assist with ISO 14971 compliant risk activities including Risk Management File documentation.
- Minimum Associates Degree in technical field. Bachelor’s Degree in related technical field preferred or equivalent.
- 2-4 years of experience in medical device industry preferred.
- Ability to interfaces with all departments in the organization in matters related to quality system compliance and functional performance of product.
- Takes direction from departmental management.
- Effective and professional communication skills; Internal (engineering, operations, management) and external (customers, auditors and suppliers) required.
- Ability to multi-task, perform job function with minimal supervision and demonstrate resiliency and high productivity in a fast-paced environment.
- Familiarity with Enterprise Resource Planning (ERP), Product Lifecycle Management (PLM) or Customer Relationship Management (CRM) software a plus.