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Complaint Handler
Bose Corporation
Framingham, MA, United States
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RESPONSIBILITIES:
• Complaint Handling:
◦ Ensure Bose FDA post-market surveillance complaint handling activities are completed on-time and in compliance with applicable US/International regulations and company procedures.
◦ Maintain daily backlog of potential complaints ensuring their disposition in Bose business systems.
◦ Work closely with Medical Device Complaint Investigators to ensure the consistent handling and documentation of customer complaints in Complaint Management Business System (JIRA).
◦ Assist in the coordination of material movement in support of Failure Analysis of Medical Devices from field returns.
◦ Interface directly with Customer Service and Retail teams to ensure the proper data capture and submission of potential complaints for Bose Medical Devices.
• General Responsibilities:
◦ Serve as primary interface for complaint handling on behalf of Quality Assurance Engineering.
◦ Support QAE and Business Unit A3 objectives partnering with New Product Quality Engineering and QMS Leadership.
◦ Ensure compliance with our Quality Management System and FDA regulatory requirements.
◦ Support potential ISO 13485 certification, CAPA’s and audits (internal and external).
◦ Drive general improvement activities for complaint handling and complaint management processes for Bose Medical Devices.
REQUIREMENTS:
• Successful candidate must have:
◦ Experience with Medical Devices in a post-sale quality capacity (Post-Market Surveillance)
◦ Strong critical thinking skills
◦ Strong written and verbal communication skills
◦ Working knowledge of Post-Market Surveillance business systems
◦ Ability to independently manage complex tasks and assignments and lead them to completion
◦ Basic understanding of fundamental Engineering Principles
◦ Ability and willingness to work at a fast pace
• Considered a strong plus:
◦ Proficient with medical device product and process risk management
◦ 4-year degree (BS) or equivalent in Engineering, Engineering Technology, IT Systems
◦ Experience with ISO 13485 Quality Management System for design and manufacture of Medical Devices, FDA
◦ Understanding of JIRA and SAP Business Systems