Sr. Quality Specialist - Data Control UDI jobs in United States
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Boston Scientific · 23 hours ago

Sr. Quality Specialist - Data Control UDI

Boston Scientific is a global leader in medical devices, and they are seeking a Sr. Quality Specialist – Data Control to ensure compliance with UDI regulations. This role involves leading data management activities, collaborating with IT on database systems, and engaging with cross-functional teams to maintain high-quality data.

Health CareMedicalMedical Device
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H1B Sponsor Likelynote

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

Qualification

Unique Device Identification (UDI)Data managementProject managementAGILE methodologyMicrosoft Office SuiteInfluencing without authorityCommunication skillsCollaboration skillsAttention to detail

Required

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

Preferred

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

Company

Boston Scientific

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Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.

H1B Sponsorship

Boston Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (114)
2024 (106)
2023 (93)
2022 (140)
2021 (111)
2020 (97)

Funding

Current Stage
Public Company
Total Funding
$10.01B
2025-02-21Post Ipo Debt· $1.57B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B

Leadership Team

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Michael Mahoney
Chairman, President & CEO
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Daniel J. Brennan
Chief Financial Officer
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Company data provided by crunchbase