Sr. Quality Specialist - Data Control UDI
bostonscientific•Valencia, MA
2d•$85,000 - $161,500
About The Position
The Sr. Quality Specialist – Data Control plays an important role on the Global Quality team in ensuring Boston Scientific’s compliance with global Unique Device Identification (UDI) regulations and other quality requirements. This position leads data management activities, collaborates with our IT partners on the development and maintenance of database systems, supports the development and maintenance of quality system procedures, and engages cross-functionally with R&D/Labeling and Regulatory teams to meet requirements and ensure high-quality data across systems.
Requirements
- Bachelor’s degree and minimum 5 years of relevant professional experience within quality
- Familiarity with interpreting requirements and/or regulations
- Ability to analyze data against requirements
- Ability to actively engage divisional and regional resources
- Excellent communication and collaboration skills
- Strong sense of responsibility and attention to detail
- Advanced Microsoft Office Suite skills
Nice To Haves
- Understanding of Unique Device Identification (UDI) requirements for medical devices
- Understanding of the BSC UDI system and procedures
- Experience as a system product owner
- Experience with AGILE methodology
- Understanding of data management / information management
- Familiarity with other BSC data systems including SAP, PDD, MDM, Snowflake, or similar
- Project management experience
- Proven ability to influence without authority
- Experience leading NCEPs and CAPAs
Responsibilities
- Lead data management activities within the BSC UDI (Unique Device Identification) system
- Support development and maintenance of quality system procedures related to UDI requirements
- Serve as a key member of the UDI database product team in the regular interactions with our IT support team
- Provide guidance on UDI interpretation questions to ensure consistent compliance to regulations and internal procedures
- Coordinate with divisional and acquisition teams on data management activities
- Support compliance analysis and metrics
- Develop and deliver communication
- Participate on or lead NCEP/CAPA teams as appropriate
- Provide project management support as needed
- Other data-related duties as necessary
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
