Description
Job Responsibilities:*Design and ensure Complaint Handling, Device Reporting and Product Return processes are compliant with domestic and international regulations (i.e. MDD, CFR and ISO13485 and other applicable regulations, Medical Device Reporting, Vigilance Reporting, Canadian Problem Reporting and other worldwide reporting requirements).
*Design and coordinate worldwide complaint processing and reporting training programs for the Complaint department and other departments as required.
*Design, distribute and educate the company and staff on product complaint and department performance metrics (e.g. weekly, monthly, quarterly, yearly).
*Collaborate with other departments as needed and in identifying, testing, and implementing work process and system improvements.
*Participate on new product design teams and create corporate strategy to launch new and sustain current products and create policies to receive product returns, investigate product complaints, process complaint documentation and report adverse events.
*Strong tactical decision-maker that works with multiple departments to obtain information, plan business strategy and handle unforeseen issues.
Management Responsibilities: The Quality Assurance Senior Manager leads the Complaint Department and carries out management responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Essential Experience:
- EU, US and Canada complaints and reporting experience
- Managed 20 or more reports
- Processed complaints worldwide
- Ability to develop complaints process
- Ability to develop MDR/Reportability process
- Master of Excel
- Hazard Analysis / Risk Management
- Bachelors Degree (technical degree preferred)
Day to Day Role:
- Hands-on as well as people management
- Processing and investigating complaints
- Providing metrics throughout the organization
- Interact w/ partners and design control
- Read and keep on top of regulations
Culture:
- Must be able to adapt to a fast paced, ever-changing organization
To find out more about Real please visit www.realstaffing.com