Boston Scientific Solution Delivery Specialist - Maternity months fixed term contract 

United Kingdom, England, Dacorum 

414678489

We’re at the forefront of the medical device industry – leading, evolving it to address unmet and emerging needs in healthcare.
Our culture powers our performance and we turn our shared vision into value with the contribution of our 36.000 colleagues around the world.

Purpose Statement

Partner with the Global Systems Project Team to, supporting Quality Systems information needs for surveillance of product performance. Additional activities include: identifying products affected by non-conformance issues, Hold Notices (Quality Notification System - QNS), Product Inquiry Report data generation and Field Action data acquisition/execution. Overall objective is to support the process of providing support for effective management of quality system information to meet the Quality System’s requirements of Boston Scientific.

Key Responsibilities

• Implementing, maintaining and improving the quality system at the EDC.
• Assist the Director Quality Assurance in all Quality related issues.
• Identifies diagnoses and solves existing process and system issues including the Global Complaint System, Global Labeling System, etc. Performs reporting tasks for product concerns by identifying affected UPNs, components, lots/batches for corrective actions, Hold Notices (QNS) and if necessary PIR and Field Actions. Serves as the “Point Person” for information relating to these activities, including recovery/replacement strategy from Field Actions.
• Works with site and the Global Systems Project Team on the information process, improvement process around the Quality Module.
• Supports the Quality team in developing and generating quality metrics reporting/tools as well as process improvements.
• Utilizes the business systems enhancement process.
• Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes.
• Executes the testing and training development for future roll-outs of business applications to new sites (e.g. Global Labeling System, Global Complaints System, Global CAPA system, Global Field Action Reporting System, and others).
• Delivers the testing and training development for new Quality application modules and releases.
• Provides ongoing user assistance and communication for the Global Complaint System, Global Labeling System, etc. working through the local quality function management.
• Develop SOP's for reporting for PIRs and Field Actions and any process changes within their site. Leads the site implementation of any applicable QM module functionality in SAP.
• Works with Business Warehouse to develop appropriate quality reports to support the business direction of global reporting.
• Executes and monitors the facility's Quality Notifications in SAP in support of the global Field Action Process.
• Communicates with cross-functional team members at all sites to gain accurate information in relating to a PIR/Field Action Reports.
• Guide and prepare site level external audits.
• Represent site Quality System with auditors.

What are we looking for in you?

• A passion for innovation and a want to learn and develop
• Hunger to succeed and excel
• Growth mentality
• Patient empathy and focus

What we can offer to you:

• Attractive benefits package
• Inspirational colleagues & culture
• Fast Growing and innovative environment
• A team-oriented company culture
• International opportunities
• Excellent training/development programmes