Job Description Summary

The Manager, Complaint Management role is responsible for investigational activities relating to infusion pumps and monitoring devices. This role manages a team of engineers and technicians and is responsible for the development, implementation, and maintenance of processes associated with complaint investigations requiring failure analysis of returned infusion systems and component parts from servicing operations. This individual will be responsible for the integrity of the investigations and ensure investigation conclusions are clear, supported, robust, and compliant. This individual will establish best practices in investigation failure analysis processes for large volumes of complaints and associated root cause determination, including inspection, test protocols and methodologies. Additionally, this individual should have strong analytical skills and effective communication across all levels of the company and demonstrate strong teamwork and collaboration across several function areas to understand product issues in the field and drive continuous product improvements.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Duties & Responsibilities

• Develops, implements, and maintains complaint investigation failure analysis processes including writing requirements, process documentation, inspection and test protocols for systems, modules and component parts.

• Design, purchase and release of investigation test fixtures for failure analysis lab. This may also include leading and performing IQ/OQ/PQ test fixture verification activities that business process deems necessary.

• Ability to solve complex problems by developing investigation test methodologies, processes & training materials.

• Serve as a domain expert for failure analyses that includes both internal functional support and external customer support with respect to analysis findings and associated improvements initiatives.

• Provide failure analysis & quality engineering expertise & consultation to significant / complex projects.

• Ensure accurate completion of complaint failure investigations and communicate with management and team members as required to ensure appropriate actions are taken to maintain timeliness goals.

• Ensure all complaint investigations have been adequately risk-assessed and initiate and escalate new failure modes for risk assessment, as required.

• Own and/or lead investigations & root cause analysis efforts for Corrective and Preventive Actions (CAPAs) when necessary. Support CAPA investigations by R&D and Operations where field return analyses may assist in those CAPA investigations. Support, and provide feedback to, monthly complaint trend reviews and resulting CAPA triggers.

• Develop, compile and present complaint investigation and failure analysis summary metrics to Senior and Executive Management, as necessary.

• Communicates investigation findings to appropriate personnel and raises to Design Quality Engineering, R&D, Operations and others on critical or emergent field issues, as necessary

• Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions).

• Ensure complaint investigation and failure analysis documentation and records are complete and in compliance with regulatory requirements.

• Participate and support internal, external audits and inspections as needed.

• Performs other related duties and activities as required: project management, resource assessments, presentation creation and strategic planning

• Implements processes for handling a large volume of complaints incoming through customer reported events and global servicing activities including, depot and field service records.

• Identifies and implements efficiency and compliance improvements to the failure analysis process.